MAUDE Adverse Event Report: ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
Medical Device Problem Codes	Defective Device (2588); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/17/2024, it was reported by a sales representative via phone that the eyelet of the swivelock's from an ar-8978-cp hand/wrist internalbrace ligament augmentation repair implant system and from an ar-8978p dx swivelock would not unthread or would not become unscrewed.The surgeon attempted multiple times without success.The case was completed using another ar-8978-cp hand/wrist internalbrace ligament augmentation repair implant system and from an ar-8978p dx swivelock.This was discovered during a scapholunate ligament reconstruction on (b)(6) 2024.The patient was not affected, and the case was only delayed to open the new implants used to complete the case.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: b3, g3, h3, h6.Based on the information provided, including the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded that the cause of the reported failure was a user error due to improper device surgical technique.The complaint allegation was not confirmed.The device was not received for evaluation, and the customer¿s attached picture does not provide evidence of the failure.

• Brand Name: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: emily shafer ; 8009337001
• MDR Report Key: 18597281
• Report Number: 1220246-2024-00591
• Device Sequence Number: 18188344
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 15091800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2023
• 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
• Patient Sex: Unknown