MAUDE Adverse Event Report: ARTHREX, INC. MINI FIBERTAPE RETRIEVER, W/ NR HANDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	MINI FIBERTAPE RETRIEVER, W/ NR HANDLE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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 01/22/2024, it was reported by a sales representative via (b)(4) that an ar-12974nr mini fibertape retriever with nr handle has a damaged working tip.This was discovered during a shoulder arthroscopy procedure on (b)(6) 2024, where they used another retriever to complete the case.There was no adverse effect on the patient.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpacked ar-12974nr serial/batch number (b)(6) was received for evaluation.During the functional test, it was noted that the finger-activated jaw mechanism is malfunctioning.The tip fails to close fully.Upon visual inspection, signs of wear and tear were observed.Notably, the top jaw of the instrument was found to be slightly bent.The reported condition is most likely caused by user error overstressing a device damaged naturally and inevitably due to normal wear or aging.Device manufactured date 2021.

• Brand Name: MINI FIBERTAPE RETRIEVER, W/ NR HANDLE
• 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: jared engle ; 8009337001
• MDR Report Key: 18685203
• Report Number: 1220246-2024-00903
• Device Sequence Number: 6249515
• Product Code: MDM
• UDI-Device Identifier: 00888867195721
• UDI-Public: 00888867195721
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/17/2024

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: MINI FIBERTAPE RETRIEVER, W/ NR HANDLE
• Device Catalogue Number: AR-12974NR
• Device Lot Number: 14456099
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown