MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

Catalog Number	657316S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the locking screw did not lock.Another screw (same size, another lot#) could be used instead of the reported screw and it could be locked, so the procedure was completed without problem.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Corrections: please refer to sections d4 (lot#) and h6 (health impact code).The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: in the received screw, the threads in the screw head are found deformed due to excess metallic contact.Threads on the shaft are in good condition which shows that the issue occurred during locking of screw.In socket of the screw head, strong stress marks with deformation can be seen which indicates that an excess torsional force has been applied in clockwise direction during tightening of the screw.Due to application of excess torsional force, the threads in the head received excess torque and got deformed leading to locking issue.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 torquing 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 a user related issue.Evidence of screw overtightening was observed, which should be avoided as it could damage the implant.As a reminder, the instructions for use clearly state that: "screws must not be over-tightened during insertion.Excessive overtightening will compromise the integrity of the screw head, resulting in possible screw breakage." 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.
Event or Problem Description
As reported: "the locking screw did not lock.Another screw (same size, another lot#) could be used instead of the reported screw and it could be locked, so the procedure was completed without problem.".

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM
• 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: 21497146
• Report Number: 0008031020-2025-00367
• Device Sequence Number: 7290512
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: (01)07613327086881(17)290331(10)AG6498
• 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): 05/28/2025

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: 657316S
• Device Lot Number: AG6498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: Male