MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM; SCREW, FIXATION, BONE

Model Number	657314S
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw did not lock to plate.When it was removed, the head broke off.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and matches the alleged failure mode.The received screw exhibited severe deformation underneath the head.Significant material removal in the form of a wire happened.The metal wire was also returned for evaluation.The nature of material deformation indicates towards application of high torque non-axially leading to shearing of material.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the issue is most likely caused due to an improper insertion of the screw intraoperatively.Nevertheless, an nc has already been opened to address this issue and similar complaints which occurred in the past.If any further substantial information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that a screw did not lock to plate.When it was removed, the head broke off.

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM
• 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: 15518707
• Report Number: 0008031020-2022-00496
• Device Sequence Number: 6055615
• Product Code: HWC
• UDI-Device Identifier: 07613327086850
• UDI-Public: 07613327086850
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 657314S
• Device Catalogue Number: 657314S
• Device Lot Number: K37075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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
• Patient Sex: Unknown