MAUDE Adverse Event Report: ARTHREX, INC. NITINOL GUIDE PIN, 1.1 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	NITINOL GUIDE PIN, 1.1 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee arthroscopy the wire broke at the laser marking.A 2cm piece of wire remained in the patients joint requiring additional surgery on (b)(6) 2023.After the second surgery all broken-off pieces could be retrieved.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique.
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-1249-1s was received for evaluation.Functional testing was not performed due to damage to the device.Visual inspection noted that the returned piece of the guide pin was bent.The returned piece was measured by drawing specification (b)(6) at revision (b)(4).Results: failed the device is shorter because of the break.The observed condition is likely due to prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: NITINOL GUIDE PIN, 1.1 MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 17699549
• Report Number: 1220246-2023-07806
• Device Sequence Number: 7399397
• Product Code: MDM
• UDI-Device Identifier: 00888867271593
• UDI-Public: 00888867271593
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/21/2024

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: NITINOL GUIDE PIN, 1.1 MM
• Device Catalogue Number: AR-1249-1S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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