MAUDE Adverse Event Report: ARTHREX, INC. WRIST SPANNING PLATE, TI; BONE FIXATION PLATE

Model Number	WRIST SPANNING PLATE, TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported by a patient that he had a wrist fusion about a year ago and the plate broke into two parts after 5 weeks.A revision surgery has been done and the plate has been replaced.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-8916spn, wrist spanning, 9 hole, batch number 047411907, was returned for investigation.Visual inspection noted that the plate was fractured at the center hole in the bend.Additionally, the threads inside the holes along the plate showed damage, likely due to the implantation and explantation process.The device also exhibited discoloration, chipping, and surface wear.Functional testing noted that the threads of the plate were damaged, and the screws encountered resistance during insertion.The most likely cause of the reported failure is a patient-specific event, attributed to fracture of the plate and subsequent revision surgery performed 5 weeks post-operatively.Per (dfu-0192-eo revision 8): ¿postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight-bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device¿.Refer to investigation photos.The complaint allegation is confirmed.

• Brand Name: WRIST SPANNING PLATE, TI
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22897862
• Report Number: 1220246-2025-03639
• Device Sequence Number: 15699495
• Product Code: HRS
• UDI-Device Identifier: 00888867183674
• UDI-Public: 00888867183674
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K143749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: WRIST SPANNING PLATE, TI
• Device Catalogue Number: AR-8916SPN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown