MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE, NARROW, R, L74MM, 7HOLES; PLATE, FIXATION, BONE

Catalog Number	625204
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "plate noted to develop significant bending deformity within first two months post operative's, plate went on to fail.Progressive pain and dysfunction noted prior to 3-month follow-up; distal radius plate broke at oblong compression hole.Revision completed and replaced with skeletal dynamics distal radius plate.
Additional Manufacturer Narrative
Correction - please refer to h6 device code.The reported event could be confirmed since the device was returned for evaluation, and with the available radiograph, it matches the alleged event.The returned plate and screws were visually inspected.Slight marks were observed on the screw heads, indicating contact from a screwdriver during insertion.The plate was fractured at its proximal section, and scratch marks were visible on the surface of the device.Multiple insertion holes showed signs of high torque application, evidenced by coating removal and visible marks.Microscopic inspection revealed deformation at one end of the proximal hole.Examination of the fractured area confirmed that the break occurred due to fatigue failure.We also see a dull surface at the end, indicating an instantaneous fracture.With the available radiograph, a formal medical opinion was sought: the volar plate was used in a case of a distal forearm fracture; both radius and ulna had a comminuted fracture.The comminuted fracture of the ulna was only held in reduction with a k-wire, allowing for shortening and putting high stresses on the plate and screws.Combined with impaired healing of the comminuted radial fracture, could lead to implant breakage.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 a combination of surgical and patient-related factors that have created a high risk for breakage of the osteosynthetic plate.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "plate noted to develop significant bending deformity within first two months post operative's, plate went on to fail.Progressive pain and dysfunction noted prior to 3-month follow-up; distal radius plate broke at oblong compression hole.Revision completed and replaced with skeletal dynamics distal radius plate.

• Brand Name: VOLAR DR PLATE, NARROW, R, L74MM, 7HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22923112
• Report Number: 0008031020-2025-01432
• Device Sequence Number: 10390083
• Product Code: HRS
• UDI-Device Identifier: 07613327615791
• UDI-Public: (01)07613327615791(10)1000588575
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K233919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: Lay User/Patient
• Device Catalogue Number: 625204
• Device Lot Number: 1000588575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 69 KG