MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE CERCLAGE TENSIONER, REUSABLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	FIBERTAPE CERCLAGE TENSIONER, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-7800, batch 051915 cerclage tensioner was received for investigation.Visual inspection identified that the spring beneath the pawl lever was no longer present on the device, impeding functionality of the cerclage tensioner.Both compression springs within the lower body component were verified to be present on the returned device.This event is most likely the result of mishandling and/or user applied mechanical forces to the pawl spring, causing it to dislodge.The missing spring was not returned for analysis.
Event or Problem Description
It was reported that the spring on the ar-7800 tensioner broke and fell out of the device.The rep reported the device did not break within the patient.The case was completed using the device and holding the ratchet mechanism down manually.

• Brand Name: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• 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: 19165511
• Report Number: 1220246-2024-02259
• Device Sequence Number: 17967906
• Product Code: LXH
• UDI-Device Identifier: 00888867273986
• UDI-Public: 00888867273986
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• Device Catalogue Number: AR-7800
• Device Lot Number: 051915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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