Medical device manufacturer, Stryker, has issued a medical device safety alert concerning its Zyphr Disposable Cranial Perforator, Large 14/11 mm [Catalogue Number: 5100-060-001; GTIN: 04546540716224; Affected Lots in Hong Kong: 20038027, 20059017, 20142037].
There is a potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use. This issue was identified internally; to date, the manufacturer has not been made aware of any adverse events related to this issue.
A crack can lead to metal fragments chipping off the bit and being retained in the surgical site, which can lead to patient injury; however, standard surgical procedure of a saline flush for debris may remove any fragments. A crack can lead to failure of the device to disengage or delayed disengagement, which can potentially cause patient injury due to unintentional cutting of cranial structures.
Affected users are instructed to immediately the following actions:
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 30 October 2020