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	10/17/2023
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
On 10/17/2023, it was reported by an arthrex employee via sems-06059402 that an ar-1255 graft passing wire had an issue.The thread for passing the graft broke during use.The case was completed without using the device with no further information provided.This was discovered during an unspecified procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation was not confirmed.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(s) for the reported failure can be a user error due to excessive forces 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: 18101864
• Report Number: 1220246-2023-08634
• Device Sequence Number: 7891285
• 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): 11/07/2024

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: 10162497
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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