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

Model Number	FIBULOCK T10 DRIVER
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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 was unable to be confirmed.Visual evaluation of photos provided by the customer identified that the driver was covered in plastic debris and appeared to have been used before.Functional testing was unable to be performed as the device was not returned.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse/mishandling during use.
Event or Problem Description
It was reported by the sales rep that the ar-8973-11, screw driver shaft requires excessive force to release screw.Screw driver shaft captured screw so tightly that it does not easily disengage.This issue caused the screw to pull out of bone of the patient.Additional information requested.Additional information provided 3/3/21: procedure being performed was a ankle fracture with fibulock.Another ankle fracture tray was opened to use a t10 screwdriver to complete the case.The bone of the patient was not harmed when the screw pulled out, but the surgeon did lose a point of fixation through the fibulock nail.

• 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: 19542912
• Report Number: 1220246-2024-05840
• Device Sequence Number: 18036231
• Product Code: LXH
• UDI-Device Identifier: 00888867302471
• UDI-Public: 00888867302471
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/14/2024

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: 1392014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown