MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS REPR; BONE FIXATION PLATE

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS REPR
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-2260 distal biceps repair implant system button inserter was too thick.This was discovered upon opening the package during a distal bicep repair procedure on (b)(3) 2023.The case was completed by opening another r-2260 distal biceps repair implant system.
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: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to an internal manufacturing issue.However, this can only be confirmed when the device is returned for evaluation.The complaint allegation was confirmed based on the customer¿s pictures which show that the shaft's tip does not fit the button.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18298468
• Report Number: 1220246-2023-09327
• Device Sequence Number: 20712977
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• 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): 03/11/2025

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: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Device Catalogue Number: AR-2260
• Device Lot Number: 15035015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 12/10/2023
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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