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

Model Number DRIVER SHAFT, T-15, MEDIUM

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2022

Event Type  malfunction  

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.

Event Description

It was reported on (b)(6) 2022 by a sales representative via sems that an ar-9545-t15-02 and ar-9545-t15-03 driver shaft are twisted.This was discovered during an unspecified time with no patient harm.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: DRIVER SHAFT, T-15, MEDIUM
• Type of Device: 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: 15657386
• MDR Text Key: 306705871
• Report Number: 1220246-2022-05649
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867225190
• UDI-Public: 00888867225190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRIVER SHAFT, T-15, MEDIUM
• Device Catalogue Number: AR-9545-T15-02
• Device Lot Number: 1392140
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1