MAUDE Adverse Event Report: ARTHREX, INC. CERCLAGE TENSIONER RATCHETING HANDLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CERCLAGE TENSIONER RATCHETING HANDLE
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a distal femur fracture surgery three fibertapes (ar-7267, lot s705864) broke inside the patient while using the cerclage tensioner (ar-7800, lot 051650).One broke during initial tensioning and the second and third broke when the final tensioning on top of the half hitch was done.All three devices broke in the knot.The broken device cerclage was removed from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device.The surgeon switched to a cerclage wire in metal.It was not necessary to do a second surgery.
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.The complaint could not be confirmed.One unpackaged ar-7801, batch 104731 cerclage tensioner ratcheting handle was received for investigation.Visual inspection identified signs of wear and tear across the device, such as discoloration across the metallic components.The observed condition of the tensioner ratcheting handle is consistent with the manufacture date of 2017.The device was functionally tested with the returned ar-7800, batch 051650 that was returned on (b)(4).No problem was noted.As the fibertape detailed in the event description was not returned, the reported failure mode cannot be verified.
Additional Manufacturer Narrative
Additional information: d9, g4, h3.H6.The complaint could not be confirmed.One unpackaged ar-7801, batch 104731 cerclage tensioner ratcheting handle was received for investigation.Visual inspection identified signs of wear and tear across the device, such as discoloration across the metallic components.The observed condition of the tensioner ratcheting handle is consistent with the manufacture date of 2017.The device was functionally tested with the returned ar-7800, batch 051650 that was returned on (b)(4).No problem was noted.As the fiber tape detailed in the event description was not returned, the reported failure mode cannot be verified.The most likely cause for the reported failure can be attributed to wear and tear.D9 - date of receipt.

• Brand Name: CERCLAGE TENSIONER RATCHETING HANDLE
• 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: 19155056
• Report Number: 1220246-2024-02223
• Device Sequence Number: 7548519
• Product Code: LXH
• UDI-Device Identifier: 00858325005176
• UDI-Public: 00858325005176
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: CERCLAGE TENSIONER RATCHETING HANDLE
• Device Catalogue Number: AR-7801
• Device Lot Number: 104731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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