MAUDE Adverse Event Report: ARTHREX, INC. #2 FW,38" W/2 TPR NDLS; POLYETHYLENE SYNTHETIC SUTURE

Model Number	#2 FW,38" W/2 TPR NDLS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
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
On 09/21/2023, it was reported by an arthrex subsidiary employee via email that fragments of a needle from an ar-7205 fiberwire were found in the patient after an x-ray was taken post-operation.The patient underwent revision surgery on (b)(6) 2023 to have the metal fragments removed.The needle had broken off during an artificial femoral head replacement surgery.No further information was provided.Additional information received on 9/26/2023: both surgeries were performed on the same day, (b)(6) 2023, and by the same surgeon.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-7205 batch number 26466 was received for evaluation.Upon visual inspection, it was noted that the suture is cut and frayed.Damage was also observed on the curved needle.Additionally, one curved needle is missing the grip attachment part.The reported failure likely stems from user error, as excessive force was applied during the tensioning process.

• Brand Name: #2 FW,38" W/2 TPR NDLS
• 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: 17958897
• Report Number: 1220246-2023-08245
• Device Sequence Number: 5033856
• Product Code: GAT
• UDI-Device Identifier: 00888867041325
• UDI-Public: 00888867041325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: #2 FW,38" W/2 TPR NDLS
• Device Catalogue Number: AR-7205
• Device Lot Number: 26466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown