MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK T10 DRIVER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FIBULOCK T10 DRIVER
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/16/2021 it was reported by a sales representative via sems that an ar-8973-11 fibulock driver is not picking up screws as expected.This was discovered during a procedure.Case was completed successfully and patient was not affected.
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 is not confirmed.Two unpackaged ar-8973-11 was received for evaluation.Visual inspection identified no apparent issues with the devices.Inspection of the hexalobe driver tip did not identify stripping.The drivers were tested against an ar-8730-38h, and mating/driving between the devices was successful.No problems were found.

• Brand Name: FIBULOCK T10 DRIVER
• 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: 19220687
• Report Number: 1220246-2024-02663
• Device Sequence Number: 7166102
• Product Code: LXH
• UDI-Device Identifier: 00888867302471
• UDI-Public: 00888867302471
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: FIBULOCK T10 DRIVER
• Device Catalogue Number: AR-8973-11
• Device Lot Number: 1392013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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