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

Model Number	SUTURE PASSING WIRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 27th june 2024, it was reported by a sales representative via email that an ar-1255-18, suture passing wire, was missing the wire loop at the end of the wire, this was detected during use in a acromioclavicular joint stabilisation procedure on (b)(6) 2024 and the missing wire loop was noticed when ar-1255-18 was advanced while it was placed through ar-2256l and the coracoid passer was passed below the patients coracoid.X rays did not reveal any obvious indication that the missing piece was in the patient, but it was not found in the surrounding area either.Operation proceeded as planned and this piece was documented as missing.The procedure was completed successfully as the passing sutures were tied to the end of the nitinol wire and shuttled across, instead of using the wire loop which had detached.
Additional Manufacturer Narrative
The lot number is either 15295461 or 15158154.But was unable to be confirmed which one.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 for the reported failure can be attributed to user error of the device due to excessive force being used when passing the suturewire.

• Brand Name: SUTURE 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: jared engle ; 8009337001
• MDR Report Key: 19760482
• Report Number: 1220246-2024-06784
• Device Sequence Number: 8479230
• Product Code: LXH
• UDI-Device Identifier: 00888867006539
• UDI-Public: 00888867006539
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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: SUTURE PASSING WIRE
• Device Catalogue Number: AR-1255-18
• Device Lot Number: 15195461 OR 15158154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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