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

Catalog Number	657314S
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
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
As reported: "plate fixation using variax fibula for right fibula fracture.During the surgery, the screw locking failed.The screw was replaced with another one (different size), and the new screw could be used without problem.".
Event or Problem Description
As reported: "plate fixation using variax fibula for right fibula fracture.During the surgery, the screw locking failed.The screw was replaced with another one (different size), and the new screw could be used without problem.".
Additional Manufacturer Narrative
Correction: please refer to d9/h3 (product available to stryker), h6 (method codes, results code, conclusion code, health impact code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Nonetheless, it could be determined that the reported event could be related to an issue already known.Related to post market surveillance activities, a potential non-conformity report (nc) 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 (capa) 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 implementaion is planned to be approved in march 2024.Therefore, the screw was manufactured before any design change took place.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 18655476
• Report Number: 0008031020-2024-00062
• Device Sequence Number: 12526621
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 657314S
• Device Lot Number: AB9780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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 Sex: Female