MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO; ORTHOPEDIC MANUAL SURG INSTR

Model Number DRIVER SHAFT, T6, SELF RETAINING, AO

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/17/2023

Event Type  malfunction  

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 Description

On 11/17/2023, it was reported by a sales representative via sems-06404429 that (qty.2) of an ar-18800-03 driver shaft twisted despite the surgeon's use of the torque limiting adapter present in the set.They were told the devices twisted before the torque limiting adapter engaged.This was discovered during an unspecified procedure, with no reported patient harm.

• Brand Name: DRIVER SHAFT, T6, SELF RETAINING, AO
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 18340621
• MDR Text Key: 331052866
• Report Number: 1220246-2023-09407
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867385566
• UDI-Public: 00888867385566
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRIVER SHAFT, T6, SELF RETAINING, AO
• Device Catalogue Number: AR-18800-03
• Device Lot Number: 1392240
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1