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

Model Number DRIVER SHAFT, T-15, MEDIUM

Device Problems Product Quality Problem (1506); Fitting Problem (2183); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the drive feature is twisted but it also broken and missing approximately.065 in.It is not stated if a torque indicating device, which is recommended to prevent damaging the device, was used.Likely causes of the event include continually applying torque when the implant is not moving; shallow driver engagement depth; prying/leveraging the device.

Event Description

It was reported that during shoulder prosthesis surgery the material is too soft and therefore it is twisted after a while of usage.The screwdriver does not fit into the screw and needs to be replaced.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with the same device used anyway.It was not necessary to switch the surgical technique or do a second surgery.No further information received.This is now reportable.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: 11990366
• MDR Text Key: 259177552
• Report Number: 1220246-2021-03251
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867225190
• UDI-Public: 00888867225190
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• 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: 8002024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1