MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L24MM; SCREW, FIXATION, BONE

Model Number	657324
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: "angular stability did not work.Screws have overrun and chips have come loose under the screw head (unfortunately, chips could not be secured).Replacement was available.Patient involvement was reported but the reporter is not aware of any impact.".
Additional Manufacturer Narrative
Correction: refer to d9/h3, h6 method code, results & conclusion code.The reported event could be confirmed.The inspection revealed a broken/deformed thread winding at the thread outlet, causing that the screw could not be locked into the plate hole.A non-conformity report (nc) was already initiated based on previous complaints reporting the same event.The nc investigation is ongoing.A review of the device history for the reported lot did not indicate any abnormalities; the screw was manufactured within specifications.A review of the risk management file showed that the reported event is adequately addressed.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "angular stability did not work.Screws have overrun and chips have come loose under the screw head (unfortunately, chips could not be secured).Replacement was available.Patient involvement was reported but the reporter is not aware of any impact.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10586229
• Report Number: 0008031020-2020-02269
• Device Sequence Number: 3143940
• Product Code: HWC
• UDI-Device Identifier: 07613327086980
• UDI-Public: 07613327086980
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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 Model Number: 657324
• Device Catalogue Number: 657324
• Device Lot Number: Y60803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1