MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,LONG, 12 HOLES; PLATE, FIXATION, BONE

Catalog Number	54-25385
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/20/2025
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: "the patient was hospitalized due to a distal fracture of the right radius.Open reduction and plate screw fixation were performed 6 days after admission.A re-examination 8 months after the operation revealed that the distal fracture of the right radius had not healed and the plate was fractured.Patient required revision surgery was completed.".
Event or Problem Description
As reported: "the patient was hospitalized due to a distal fracture of the right radius.Open reduction and plate screw fixation were performed 6 days after admission.A re-examination 8 months after the operation revealed that the distal fracture of the right radius had not healed and the plate was fractured.Patient required revision surgery was completed.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,LONG, 12 HOLES
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22287652
• Report Number: 0008031020-2025-00980
• Device Sequence Number: 15531243
• Product Code: HRS
• UDI-Device Identifier: 07613154345519
• UDI-Public: (01)07613154345519(10)1000226977
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 54-25385
• Device Lot Number: 1000226977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2016
• 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: 69 YR
• Patient Sex: Unknown