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	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The sales representative reported a case that had a locking screw fail to lock.Hole was intended to be filled with a 16mm locking screw.The screw had all the hallmarks of being a locking screw (head of screw was grey) however as the screw became seated in the plate it failed to lock and just was spinning in the plate.Multiple attempts were made and then this was swapped to a 14mm which locked with no issues.Delay to procedure: 5-10 minutes.
Additional Manufacturer Narrative
Correction: please refer to d9: the product was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and with provided image, we cannot confirm the alleged event.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 related the reported failure mode regarding the locking of the variax2 screw it can be mentioned that as part of our post market surveillance activities a potential non-conformity report was initiated to address similar events related to the variaax2 locking feature.The deep 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 variax2 system clearly states that the proper use of the screw should prevent this deformation 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.However, although no product related issue could be detected a preventive action capa was nonetheless opened to make the design more robust against a potential over tightening by the user.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If any further information is provided or the device is returned, the complaint report will be updated.
Event or Problem Description
The sales representative reported a case that had a locking screw fail to lock.Hole was intended to be filled with a 16mm locking screw.The screw had all the hallmarks of being a locking screw (head of screw was grey) however as the screw became seated in the plate it failed to lock and just was spinning in the plate.Multiple attempts were made and then this was swapped to a 14mm which locked with no issues.Delay to procedure: 5-10 minutes.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19722553
• Report Number: 0008031020-2024-00266
• Device Sequence Number: 20884760
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: AF2372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2024
• 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: Unknown