MAUDE Adverse Event Report: ARTHREX, INC. FW BPB #5 SUTR,BLU W/NDL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FW BPB #5 SUTR,BLU W/NDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/8/2024, it was reported by a facility risk manager via an fda maude review email that the tip of the needle from ar-7211 fiberwire broke off in the patient's bone.This was discovered during a procedure on (b)(6) 2024.
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
Mw5153206.
Additional Manufacturer Narrative
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 for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: FW BPB #5 SUTR,BLU W/NDL
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19258078
• Report Number: 1220246-2024-02873
• Device Sequence Number: 6519860
• Product Code: GAT
• UDI-Device Identifier: 00888867041417
• UDI-Public: 00888867041417
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2025

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: FW BPB #5 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7211
• Device Lot Number: 27796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/17/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/22/2024; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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