MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T-15, MEDIUM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2022 by a sales representative via sems that an ar-9545-t15-02 driver shaft and ar-9545-t15-03 driver shaft is stripped.This was discovered during a case with no patient harm.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.Upon visual inspection it was noted that the drive geometry at the distal tip of the returned ar-9545-t15-02 had both twisted and broken.No fragments were returned for inspection.It was not indicated if a torque-indicating adapter had been used with the device.A probable cause is attributed to over-torquing/over-engaging the driver within the screw head.

• Brand Name: DRIVER SHAFT, T-15, MEDIUM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15657398
• Report Number: 1220246-2022-05650
• Device Sequence Number: 6377665
• Product Code: LXH
• UDI-Device Identifier: 00888867225190
• UDI-Public: 00888867225190
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/24/2022

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 SHAFT, T-15, MEDIUM
• Device Catalogue Number: AR-9545-T15-02
• Device Lot Number: 8002024
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown