FDA Adverse Event Malfunction Summary report: N

HANDLE, T, KEYLESS CHUCK CANNULATED

MDR report key: 19489505 · Received June 7, 2024

Report

Report Number: 1220246-2024-05178
Event Type: Malfunction
Date Received: June 7, 2024
Date of Event: March 4, 2022
Report Date: June 7, 2024
Manufacturer: ARTHREX, INC.
Product Code: LXH
UDI-DI: 00888867055247
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER DETERGENT/CLEANING PROCESS USED. AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED.

Description of Event or Problem · 0

ON 03/06/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-8954-02 T-HANDLE LOT: 78421725, BROKE IN HALF. THIS WAS DISCOVERED DURING USE IN A DURING A CALCANEAL FRACTURE REPAIR PROCEDURE ON (B)(6) 2022. THE SURGEON OPENED A SECOND 3.5/4.0 AND THE AR-8954-02 T HANDLE LOT:78421642 WAS LOCKED AND RUSTED. REQUESTED ADDITIONAL INFORMATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1263929	HANDLE, T, KEYLESS CHUCK CANNULATED	ORTHOPEDIC MANUAL SURG INSTR	LXH	ARTHREX, INC.	HANDLE, T, KEYLESS CHUCK CANNULATED	78421642	00888867055247

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown