MAUDE Adverse Event Report: STRYKER GMBH EXTENDED VOLAR DR PLATE, WIDE, L, L81MM, 7HOLES; PLATE, FIXATION, BONE

Catalog Number	625255
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the initial surgery on this implant was done on (b)(6), and yesterday we did a surgery to remove the implant because the plate had broken from the second to most proximal screw plate broke in half.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that the initial surgery on this implant was done on (b)(6) and yesterday we did a surgery to remove the implant because the plate had broken from the second to most proximal screw plate broke in half.
Additional Manufacturer Narrative
Correction - please refer to d9, the device was returned for evaluation.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received plate was found to be broken from the round hole in the middle just above the oblong hole.The nature of breakage exhibited the typical characteristics of a fatigue failure with slight plastic deformation along the edges and on the surface, mostly caused due to constant rubbing under gradual separation.Signs of heavy stress concentration were observed along one of the sides of the broken surface, evident by secondary fracture line and edges pressed back against the surface.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A couple of x-rays that were provided were presented to our hcp who opined that the fracture is still visible even after 12 weeks with hardly any signs of healing and also the placement of plate could have been further optimized.Based on the available information and above investigation, the plate broke in a fatigue manner where the root cause of the issue is multifactorial: the location of the fracture and the technical aspects of the surgical procedure most likely contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and therefore, the breakage of the implants.The ifu clearly instructs the user that: these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.If any additional information is provided, the investigation will be reassessed.

• Brand Name: EXTENDED VOLAR DR PLATE, WIDE, L, L81MM, 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: 22676736
• Report Number: 0008031020-2025-01314
• Device Sequence Number: 9566006
• Product Code: HRS
• UDI-Device Identifier: 07613327614947
• UDI-Public: 07613327614947
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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
• Device Catalogue Number: 625255
• Device Lot Number: 1000559155
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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 Sex: Unknown