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	Expiration Date Error (2528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex subsidiary employee via email that an expired ar-7200-1, fiberwire® #2 braided polyblend suture, blue, w/ tapered needle, implant was used on patient.This was detected on (b)(6) 2023 during a left meniscal repair procedure.The procedure was completed successfully.
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
Additional information: d9, g3, h6.The complaint allegation was confirmed.The most likely cause of the reported failure is a user error, as the device's expiration was not verified before the procedure.The failed device was not received for evaluation.An evaluation of the picture attached to the complaint confirms the allegation.The device ar-7200-1, batch 20021, was expired at the time of the procedure.A more in-depth evaluation of the device history record found that the device's shelf-life label in months was only 48 (4 years).Per agile finished good details.Shelf life (months) is 60 (5 years).

• 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: emily shafer ; 8009337001
• MDR Report Key: 18486078
• Report Number: 1220246-2024-00239
• Device Sequence Number: 16830980
• Product Code: GAT
• UDI-Device Identifier: 00888867280908
• UDI-Public: 00888867280908
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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 Expiration Date: 08/31/2023
• Device Model Number: FW,BPB #2 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7200-1
• Device Lot Number: 20021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2018
• 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