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

Model Number T10 HEXALOBE, CMP FT

Device Problems Break (1069); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2022

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 5/19/2022, it was reported by a sales representative via sems that thee ar-8737-38 driver shaft broke.While implanting the 3.5mm headless compression screw, it was difficult to advance it into the far cortex of the metatarsal.Surgeon attempted to drive the screw into the desire position when it bent and then broke.This was discovered during an osteotomy fixation of the first metatarsal on 5/12/2022.Additional information received on 5/25/2022: three drivers broke consecutively inside the patient and all fragments were retrieved.The case was completed by muscling the screw down with the three drivers and when it wouldn¿t drive down any further and the screw was sitting proud, the surgeon burred off the medial portion of the screw to make it as flush to bone as possible.The driver handle ar-8950rh, from the compression ft set, was used to complete case.

• 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: 14603906
• MDR Text Key: 301107059
• Report Number: 1220246-2022-05046
• 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
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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
• Device Lot Number: 1392018
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/19/2022
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1