Medical device manufacturer, Stryker GmbH, has issued a medical device safety alert concerning its Pin To Rod Coupling Hoffmann II Compact 5/3-4mm. The affected product can be identified as follows:
The manufacturer has received a complaint for the affected product. The hospital reported that the affected product could not clamp the pin and rod as intended. The situation caused a surgical delay of 15 minutes, however the procedure was completed by using a product with a different lot number.
The non-functioning coupling was returned to the manufacturer, the investigation of the situation revealed that the coupling of the reported lot number is wrongly assembled by the manufacturer. The pin component of the lot number above is mixed up with the rod component. Therefore, the coupling is not functional. The non-conformance is limited to one lot number.
According to the manufacturer, the deviation can cause a prolongation of surgery time, a change of surgery method and potentially a revision surgery. Conservative fracture treatment with plaster cast is usually available and could complete the fracture treatment .The defect is not easily recognizable for the user. The wrongly assembled Pin to Rod Coupling looks very similar to a correctly assembled coupling. However, it can be recognized, if functionality is tested before the surgery.
The following can potentially solve the situation during surgery to complete the surgery successfully:
a. A spare Kit is available
b. Spare Pin to Rod couplings are available
c. Another external fixator system is available
d. Conservative fracture treatment with plaster cast is available
Customers are advised to immediately check the storage to determine, quarantine and discontinue use of the affected product. Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 November 2019