MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L10MM; PLATE, FIXATION, BONE

Catalog Number	657310S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the locking screw on the variax fibula plate failed to lock.After opening another screw, the surgery was completed without any problems".
Event or Problem Description
As reported: "the locking screw on the variax fibula plate failed to lock.After opening another screw, the surgery was completed without any problems".
Additional Manufacturer Narrative
Correction - please refer to h6 health impact code.The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: usage marks and discoloration were observed on the screw head and its threads.The threads at the head level are heavily worn out, as they are not sharp anymore.Furthermore, the screw head is damaged and discolored.These damages were most likely caused by excessive force applied during the failed locking attempts of the screw.Finally, the threads at the shaft level also appear to worn out, implying contact between the shaft and the plate occurred, most probably caused by an off-centered entry of the screw.The returned screw was tested with compatible and fully functional variax 2 plate, also intended for t10 locking screws.The screw could be locked as intended, no issue was observed.Therefore, the functionality of the device was still fully given and the reported event could not be confirmed.It is worth noting a potential non-conformity report was initiated to address similar events related to the variaax2 locking feature.The investigation of the nc revealed the over torqueing during insertion was the root cause of the event.Although no product related issue could be detected, a preventive action (capa) was opened.As a result, the design of the variax 2 locking screws shall be changed to increase the torque to failure of the locking interface.The screw involved in the reported event was manufactured before any design change took place.Based on investigation, the root cause was attributed to an user related issue.The reported event was most probably caused by inadequate insertion and locking of the screw, since the returned device is conforming to specifications and fully functional.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 more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L10MM
• Common Device Name: PLATE, 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21417486
• Report Number: 0008031020-2025-00336
• Device Sequence Number: 12730518
• Product Code: HRS
• UDI-Device Identifier: 07613327086799
• UDI-Public: (01)07613327086799(17)271231(10)K78290
• 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): 04/28/2025

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 Catalogue Number: 657310S
• Device Lot Number: K78290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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 Age: 34 YR
• Patient Sex: Male
• Patient Weight: 70 KG