MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L18MM; SCREW, FIXATION, BONE

Model Number	657318S
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "wire-like shavings were produced during insertion of the screw.Since the screw did not lock, a new screw was replaced and the operation was terminated.".
Additional Manufacturer Narrative
Please note correction to h6 (device code).The reported event could be confirmed, since the device was returned, and matches the alleged failure.The device inspection revealed the following: the head of the returned screw is heavily worn out on the inside, the deformation is caused by overtightening of the screw and alignment of the screw out of the advised angulation during insertion.The damage observed led to the formation of fragments.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.Based on the investigation, the root cause was attributed to a user related issue as there is a sign of overtightening on the screw.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "wire-like shavings were produced during insertion of the screw.Since the screw did not lock, a new screw was replaced and the operation was terminated.".

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16474005
• Report Number: 0008031020-2023-00102
• Device Sequence Number: 20777130
• Product Code: HWC
• UDI-Device Identifier: 07613327086904
• UDI-Public: 07613327086904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/09/2023

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: 657318S
• Device Catalogue Number: 657318S
• Device Lot Number: K55896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown