MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DR PLATE, WIDE, LONG; PLATE, FIXATION, BONE

Catalog Number	54-25399
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/13/2025
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: "volar plate broken.The issue was discovered when patient went to emergency services reporting pain.Patient reported pain and medical intervention was required.".
Additional Manufacturer Narrative
Correction: please refer to section d4 lot#.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 in two after 21 weeks of implantation at the level of the 8th distal locking hole, both fragments were returned.Microscopic analysis gives evidence of a fatigue fracture on the lateral side of the place.The medial side gives indication of a sudden "catastrophic" brittle fracture, resulting from the fatigue fracture aforementioned.Despite the confirmation of the reported event, it was not possible to determine its exact root cause.Additional information, such as patient's medical reports and patient post-operative behavior as well as x-ray images would have been necessary to perform a complete investigation and to understand what may have cause the implant's failure.It must be noted that any manufacturing or design related issue could be ruled out.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.
Event or Problem Description
As reported: "volar plate broken.The issue was discovered when patient went to emergency services reporting pain.Patient reported pain and medical intervention was required.".
Additional Manufacturer Narrative
Correction: please refer to section h6 (device code).
Event or Problem Description
As reported: "volar plate broken.The issue was discovered when patient went to emergency services reporting pain.Patient reported pain and medical intervention was required.".

• Brand Name: VOLAR SMARTLOCK DR PLATE, WIDE, LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22287477
• Report Number: 0008031020-2025-00976
• Device Sequence Number: 12855484
• Product Code: HRS
• UDI-Device Identifier: 07613153068426
• UDI-Public: (01)07613153068426(11)190716(10)1000366382
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: Lay User/Patient
• Device Catalogue Number: 54-25399
• Device Lot Number: 1000366382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 10/02/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/02/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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