MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS, BC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 27-jan-2026, a sales representative reported via (b)(4) that an ar-2260bc implant delivery system had bent.This occurred during a case while inserting the button properly, and the tip of the inserter bent, rendering the device unable to hold the button and therefore unusable.A new kit had to be opened to complete the case.No harm was done to the patient.Additional information was provided on 02-feb-2026 where the sales representative reported via (b)(4) that this event occurred during a distal biceps repair on (b)(6) 2026.The patient had good bone quality, that was prepped using a spade-tip pin from the kit and a reamer corresponding to tendon size.All fragments were retrieved from the patient.A new kit was used to complete the case.This event resulted in a five-minute delay which did not require additional anesthesia.Additional information was provided on 04-feb-2026 where the sales representative reported via (b)(4) that the device only bent.There were no fragments.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 24337633
• Report Number: 1220246-2026-00587
• Device Sequence Number: 21275408
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/01/2026

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, BC
• Device Catalogue Number: AR-2260BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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