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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
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 that during a surgery the wire had a bend/curve in the middle.This meant that it was not possible to drill through with the large, cannulated drill bit.Per complaint reporter there was no harm for patient, operator or third party.No further information provided.
Additional Manufacturer Narrative
The reported event was confirmed.The only part received from the kit for evaluation was the spear of the component c0474 (biceps button drill pin unsterile).The visual evaluation of the received device noted that the spear is slightly bent caused by a fretting mark in the middle of the device (see evaluation pictures 2 + 3).The most likely cause of this failure is attributed to wear and tear resulting from repeated insertion and/or removal of the device, as well as extended use in the field.The most likely cause is due to mechanical damage with another instrument/tool while using excessive force.
Additional Manufacturer Narrative
The reported event was confirmed.The only part received from the kit for evaluation was the spear of the component c0474 (biceps button drill pin unsterile).The visual evaluation of the received device noted that the spear is slightly bent caused by a fretting mark in the middle of the device (see evaluation pictures 2 + 3).The most likely cause is due to mechanical damage with another instrument/tool while using excessive force.

• 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: jared engle ; 8009337001
• MDR Report Key: 23629929
• Report Number: 1220246-2025-05148
• Device Sequence Number: 21452106
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: (01)00888867026476(11)250623(17)300531(10)15454661
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2026

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: 15454661
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 03/09/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/10/2026; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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