MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE RETRIEVER W/ NR HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	FIBERTAPE RETRIEVER W/ NR HANDLE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2022
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 (b)(6) 2022, it was reported by a sales representative via phone that an ar-13974nr fiber tape retrieve tip broke inside the patients shoulder.Surgeon was able to retrieve the broken fragment.This was discovered during a cuff mend repair on (b)(6) 2022.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-13974nr retriever was received for investigation.Visual inspection identified that the distal end of the 113-4053 retriever jaw had broken off.No fragments were returned with the main assembly.The cause remains undetermined, although probable causes can be attributed to using the device to grasp and manipulate tissue, or through applying excessive leveraging forces during use.

• Brand Name: FIBERTAPE RETRIEVER W/ NR HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13757193
• Report Number: 1220246-2022-04580
• Device Sequence Number: 20413765
• Product Code: LXH
• UDI-Device Identifier: 00888867015791
• UDI-Public: 00888867015791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/27/2022

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: FIBERTAPE RETRIEVER W/ NR HANDLE
• Device Catalogue Number: AR-13974NR
• Device Lot Number: 83473
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown