MAUDE Adverse Event Report: ARTHREX, INC. GRAFT PASSING WIRE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GRAFT PASSING WIRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a subsidiary representative via sems that an ar-1255 graft wire snapped at the loop during a procedure.
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
Complaint confirmed.One unpackaged ar-1255 was received for investigation.Visual inspection found that the strand braided nitinol loop was broken.The diameter of the loop was measured by the drawing specification, and the result was pass.Indicating the loop of the device was as drawing specifications.Drawing c8732 at revision 7.The most likely cause of the reported issue is excessive force during use.

• Brand Name: GRAFT PASSING WIRE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 17683820
• Report Number: 1220246-2023-07780
• Device Sequence Number: 16796608
• Product Code: LXH
• UDI-Device Identifier: 00888867006492
• UDI-Public: 00888867006492
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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): 11/06/2024

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: GRAFT PASSING WIRE
• Device Catalogue Number: AR-1255
• Device Lot Number: 10216711
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• 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