MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; SCREW, FIXATION, BONE

Model Number	657316S
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2020
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: "during the initial operation on (b)(6) 2020, the locking screw did not lock to the plate.So, the screw was removed.When it was pulled out, thread-shaped metal pieces [.] was found.After screw was exchanged with new one, it was able to lock without problem.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the pictures provided confirm the reported event: a metallic wire of what looks like the thread under the screw head has detached from the screw.This is most probably the result of the application of an inappropriate angulation during the insertion of the screw, paired with significant force.The combination of these two factors could have resulted in the shearing of the screw threads against the plate, resulting in the metallic wire.Based on investigation, the root cause was attributed to be user related.The failure was caused by an inadequate handling of the device.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: "during the initial operation on (b)(6) 2020, the locking screw did not lock to the plate.So, the screw was removed.When it was pulled out, thread-shaped metal pieces [.] was found.After screw was exchanged with new one, it was able to lock without problem.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10423136
• Report Number: 0008031020-2020-02177
• Device Sequence Number: 11560860
• Product Code: HWC
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• 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
• Report Date (Section B): 10/21/2020

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: 03/31/2025
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: G21680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1