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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a distal biceps tendon refixation the suture has torn while knotting / working with it.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6)2025.Further information was provided that the broken sutures were removed out of the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Visual evaluation of the ar-2260 shows the suture torn and frayed.Functional testing could not be performed due to the damage to the device.Complaint allegation is confirmed.The most likely cause for the reported event can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• 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: 21347096
• Report Number: 1220246-2025-00351
• Device Sequence Number: 18101660
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: (01)00888867026476(11)240307(17)290228(10)15217170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 15217170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2024
• 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