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

Catalog Number	54-25687
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "on (b)(6) 2025, the surgeon operated on a patient whose indication was: ¿various open fractures of the right forearm.¿ on (b)(6) 2025, during post-operative imaging, one of the plates inserted was found to be broken.The patient therefore had to undergo further surgery on (b)(6) 2025 to have the plate removed.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could be confirmed during the investigation.A device inspection was not possible since the affected device was not returned.A photo of the broken plate has been received, confirming the reported event.Nonetheless, based on the photo only, it was not possible to determine the root cause of the breakage.Note: the catalog and lot number are not visible on the photo received.More detailed information about the complaint event, such as x-ray images and patient medical records, as well as the affected device must be available in order to determine the root cause of the complaint event.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.
Event or Problem Description
As reported: "on (b)(6) 2025, the surgeon operated on a patient whose indication was: ¿various open fractures of the right forearm.¿ on (b)(6) 2025, during post-operative imaging, one of the plates inserted was found to be broken.The patient therefore had to undergo further surgery on (b)(6) 2025 to have the plate removed.".
Event or Problem Description
As reported: "on (b)(6) 2025, the surgeon operated on a patient whose indication was: ¿various open fractures of the right forearm.¿ on (b)(6) 2025, during post-operative imaging, one of the plates inserted was found to be broken.The patient therefore had to undergo further surgery on (b)(6) 2025 to have the plate removed.".
Additional Manufacturer Narrative
Please note the corrections to d4 lot #, d4 gtin, d9 and h4.The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned plate could be confirmed based on the catalog and the lot numbers marked.The plate broke at the oblong hole in two parts, confirming the reported event.Both fragments have been returned.The distal part of the plate is highly bent.The surface of the breakage gives indication of a sudden brittle fracture under excessive bending load, as indicated by the flat fracture planes and the uniform roughness across the surface.Given the deformation of the plate, a ductile fracture was to be expected.Which is not the case here.The brittle fracture observed can be explained by a rapid initiation and progression of the fracture when the surface is tensile while being bent (lateral side under compression and medial side under tension).This is confirmed by the shape of the distal portion of the plate close to the breakage area.Nonetheless, it was not possible to determine the exact root cause of the breakage.X-ray images would have been necessary to conduct a full investigation.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 more information is provided, the case will be reassessed.

• Brand Name: VOLAR DR PLATE INTERM. RIGHT LONG
• 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: 23123103
• Report Number: 0008031020-2025-01629
• Device Sequence Number: 9325909
• Product Code: HRS
• UDI-Device Identifier: 07613252614548
• UDI-Public: (01)07613252614548(10)1000263958
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

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: 54-25687
• Device Lot Number: 1000263958
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 02/20/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/11/2025; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2017
• 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: 56 YR
• Patient Sex: Male