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

Catalog Number	657314S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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
The locking screw could not be locked to the plate.
Event or Problem Description
The locking screw could not be locked to the plate.
Additional Manufacturer Narrative
Correction - h6 health impact code.The reported event could not be confirmed since the returned device was found fully functional during inspection.The device inspection revealed the following: in the received screw, initial thread in the head found slightly deformed most probably due to excess torsional force.It looks like the screw has been inserted, possibly with an angulation outside of the range advised (-15 degrees to 15 degrees) and over torquing has resulted in minor deformed of the thread.Other than that, no further abnormalities were observed.A functional inspection was done on the returned screw using a sample plate and it was found that the screw could be easily inserted into the plate.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 or manufacturing related problems were found during the investigation.Based on the investigation, the root cause was attributed to be a user related issue as the device is found fully functional and could be assembled as per instructions indicated in the operative technique.However previously (not in this case), a potential non-conformity report was initiated to address similar events related to the variaax2 t8 and t10 locking feature.The investigation of the nc revealed that the application of over torque during insertion was the root cause of the event.This leads to the damage of the smart lock technology below the head.As a reminder, the operative technique clearly states that the proper use of the screw should prevent this malfunction from happening.Caution: with the use of variable speed power systems, the surgeon should initially reduce the power to the lowest setting.Final tightening of the screw should be performed by hand to avoid damaging the screw-plate interface.Although no product related issue could be detected, a preventive action was opened.As a result, the design of the variax 2 locking screws t10, 3.5mm ref 657308(s)-70(s) and t10, 2.7mm ref 657008(s)-70(s) shall be changed to increase the torque to failure of the locking interface.The implementation is planned to be approved in june 2024.Therefore, the screw was manufactured before any design change took place.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20494931
• Report Number: 0008031020-2024-00605
• Device Sequence Number: 11666556
• Product Code: HRS
• UDI-Device Identifier: 07613327086850
• UDI-Public: (01)07613327086850(17)290331(10)AG7889
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 657314S
• Device Lot Number: AG7889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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: Unknown