Medical device manufacturer, Synthes, has initiated a product recall of certain bone screws. The affected part numbers are 04.019.030; 04.019.038; 04.019.040; 04.019.042; 04.019.046; 04.019.054; 412.105; 412.118; 413.012; 413.016; 413.018; 413.022; 413.024; 413.026; 413.028; 413.040S; 413.044S; 413.052; 413.070S; 413.314; 413.326; 413.330; 413.330S; 413.332; 413.332S; 413.334; 413.336; 413.338; 413.338S; 413.340; 413.340S; 413.342; 413.344; 413.350S; 413.355S; 413.360; 413.360S; 413.365; 413.375; 413.380; 413.385; 413.414; 413.465 and 422.396-US.
Synthes received a complaint by a surgeon that a MultiLoc screw with a deformed cross-hole was identified in the Loan Office. The root cause is related to an employee failed to follow established processes.
The manufacturer explains that the presence of a screw that is out of specification may be detected prior to insertion. In this situation it is likely that the surgical delay would be minimal while an alternative screw is located and inserted. The screw may also be difficult to insert and/remove due to the non-conformance. If the screw was inserted and the non-conformance was detected after implantation, a surgical delay may result, during removal, exposing the patient to increased amounts of anesthesia and IV fluids.
One the other hand, if the non-conforming screw is not detected by the surgeon and the index procedure is completed, there is the potential that the screw will not perform as anticipated during the post-operative recovery period. The non-conforming screw has a smaller outer diameter, hence there is an increased risk of screw loosening and backout in this scenario. This can result in prolonged healing, pain, and the need for an additional surgical intervention. Permanent impairment is not anticipated.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 21 August 2013