MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE INTERM. LEFT SHORT; PLATE, FIXATION, BONE

Catalog Number	54-25674
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "a dorsal wedge osteotomy was performed to achieve increased radial height and correct the distal dorsal deformity of the radius.The plate was fixed distally using locking screws, and with the use of a lamina spreader, greater radial height was obtained, which was confirmed via x-ray.The plate was then fixed proximally using a cortical screw; however, plate failure was observed due to bending.As a result, the surgeon proceeded to remove the plate and replace it with a new one.".
Event or Problem Description
As reported: "a dorsal wedge osteotomy was performed to achieve increased radial height and correct the distal dorsal deformity of the radius.The plate was fixed distally using locking screws, and with the use of a lamina spreader, greater radial height was obtained, which was confirmed via x-ray.The plate was then fixed proximally using a cortical screw; however, plate failure was observed due to bending.As a result, the surgeon proceeded to remove the plate and replace it with a new one.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received device was visually inspected and found to be bent at the section of the oblong hole.Heavy deformation is evident in the form of deep scratches, which have caused a dent inside the blade, indicating the application of significant force.Additionally, prominent marks are visible near the oblong hole, suggesting that the plate was held at this section for contouring or bending.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.Based on the investigation, the root cause can be attributed to user related as the device deformation indicate application of excessive force while contouring the device.If more information is provided, the case will be reassessed.

• Brand Name: VOLAR DR PLATE INTERM. LEFT SHORT
• 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: 23186701
• Report Number: 0008031020-2025-01655
• Device Sequence Number: 21285883
• Product Code: HRS
• UDI-Device Identifier: 07613252614463
• UDI-Public: (01)07613252614463(10)1000557231
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 54-25674
• Device Lot Number: 1000557231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male