MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L20MM; SCREW, FIXATION, BONE

Model Number	657320S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the locking screw did not lock.So, the screw was exchanged with other lot one and reinserted but it did not lock, either.".
Additional Manufacturer Narrative
Due to the current covid-19 pandemic, it was not possible to access the product at the facility due to restrictions.The device inspection will be performed once the restriction is lifted.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "the locking screw did not lock.So, the screw was exchanged with other lot one and reinserted but it did not lock, either.".
Event or Problem Description
As reported: "the locking screw did not lock.So, the screw was exchanged with other lot one and reinserted but it did not lock, either.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the reported event.A device inspection shows that the thread below the head of the screw is damaged plastically, resulting in the impossibility to lock the screw with the plate, since two threads of the locking mechanism have been stuck together.This is consistent with an improper insertion of the screw by the user.The root cause of the event can be attributed to be user related.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10051944
• Report Number: 0008031020-2020-01484
• Device Sequence Number: 3357744
• Product Code: HWC
• UDI-Device Identifier: 07613327086942
• UDI-Public: 07613327086942
• Combination Product (Y/N): N
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 657320S
• Device Catalogue Number: 657320S
• Device Lot Number: D33357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/17/2020; 08/11/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/14/2020; 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1