MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DRIVER, T10 HEXALOBE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
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
It was reported that during an ankle joint surgery the device twisted.A part of the device broke off inside the patient, but all fragments were retrieved.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update 21-jun-2022 it was confirmed that no part of the device broke off and remained inside the patient.During unscrewing, too much force was used.Therefore the defect occurred.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8944dh driver was received for investigation.Visual inspection identified that the drive geometry at the distal tip of the returned ar-8944dh was chipped and twisted.A likely cause is attributed to over-torquing/over-engaging the driver within the screw head.

• Brand Name: DRIVER, T10 HEXALOBE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 14976733
• Report Number: 1220246-2022-05190
• Device Sequence Number: 5073541
• Product Code: MDM
• UDI-Device Identifier: 00888867053045
• UDI-Public: 00888867053045
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: DRIVER, T10 HEXALOBE
• Device Catalogue Number: AR-8944DH
• Device Lot Number: 1391852
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown