MAUDE Adverse Event Report: ARTHREX, INC. T10 HEXALOBE, CMP FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number T10 HEXALOBE, CMP FT

Device Problems Break (1069); Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a facility representative via email that an ar-8730-46h mini compression ft screw after being advance about three fourths of the way the screw stopped and would not advance any longer.The screw was stuck and would not back out either, the tip of an ar-8737-38 driver broke while attempting to remove it.A second driver was able to remove the screw with a lot of force and torque this cause the driver tip to warp and the screw to bend but did not complete break.This was discovered during a metacarpal fraction procedure on (b)(6) 2022.

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.

Manufacturer Narrative

Complaint confirmed.Upon visual inspection, it was noted that the distal tip of the device was twisted and broken.The broken piece was not returned for investigation.Relevant dimensions could not be measured due to the damage to the device.

• Brand Name: T10 HEXALOBE, CMP FT
• 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: 15183072
• MDR Text Key: 304972801
• Report Number: 1220246-2022-05335
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867127166
• UDI-Public: 00888867127166
• 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,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T10 HEXALOBE, CMP FT
• Device Catalogue Number: AR-8737-38
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1