MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX, CMP FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 1.5MM HEX, CMP FT

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

On (b)(6)2022, it was reported by a sales representative via email that (2) ar-8737-37 driver shaft and one ar-8737-45 driver shaft broken trying to remove a screw.This was discovered during an scaphoid fragment on (b)(6)2022.Additional information received on (b)(6)2022: all three drivers broke consecutively and all the fragments were retrieved from inside the patient.Although the devices broke, surgeon was able to remove the screw with them.

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.

• Brand Name: 1.5MM HEX, 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: 14976265
• MDR Text Key: 304368916
• Report Number: 1220246-2022-05193
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867127159
• UDI-Public: 00888867127159
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.5MM HEX, CMP FT
• Device Catalogue Number: AR-8737-37
• Device Lot Number: 1391622
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2022
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1