MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE, STANDARD, R, L47MM, 3HOLES; PLATE, FIXATION, BONE

Catalog Number	625210S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "difficulty in locking the second distal ulnar locking hole.".
Event or Problem Description
As reported: "difficulty in locking the second distal ulnar locking hole.".
Additional Manufacturer Narrative
Please note correction to d9 (product available to stryker).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.In general following statements from the variax 2 distal radius instructions for use (v15410 rev ac, 03-2024) can be pointed out in relation to the reported event: "-screws should not be over-tightened during insertion.Excessive over-tightening will compromise the integrity of the screw, screwdriver blade and plate which may result in metal debris generation, stripping of locking threads, breakage or deformation, and lead to loosening.- if excessive resistance is felt during screw insertion or if the bone is dense, it is recommended to use the tap.- final tightening of each variax 2 locking or bone screw should be carefully completed by hand to verify a rigid connection between the screw and plate.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: VOLAR DR PLATE, STANDARD, R, L47MM, 3HOLES
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23453378
• Report Number: 0008031020-2025-02026
• Device Sequence Number: 20825410
• Product Code: HRS
• UDI-Device Identifier: 07613327615470
• UDI-Public: (01)07613327615470(17)300602(10)1000601526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233919
• 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): 12/22/2025

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: 625210S
• Device Lot Number: 1000601526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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