MAUDE Adverse Event Report: ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FW,BPB #2 SUTR,BLU W/NDL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a cruciate ligament surgery the sutures are torn off close to the implant.This happened with 6 devices and the sutures tore at the same place.All device fragments were removed from the patient.The surgeon had to switch to open surgery to finish the cruciate ligament surgery.The surgery took more than 3 hours due to the device failures.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Upon visual inspection, the fiberwire® #2 braided polyblend suture, blue, w/ tapered needle returned did not have any issues with the sutures and/or needle attached.The braid component and needle pull test passed the requirements per the certification received from the supplier and arthrex records.However, the broken sutures/needles were not returned, nor was a photograph provided for a proper investigation.No issues were found with the packaging materials.The most likely cause of the reported failure can be attributed to user error of the device due to excessive force during suture passing, tightening, or tensioning, as well as incorrect bone preparation or contact with sharp instruments during use.

• Brand Name: FW,BPB #2 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: 19466786
• Report Number: 1220246-2024-04905
• Device Sequence Number: 16998787
• Product Code: GAT
• UDI-Device Identifier: 00888867041264
• UDI-Public: 00888867041264
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• 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): 10/14/2024

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 #2 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7200
• Device Lot Number: 28038
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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