FDA Adverse Event Malfunction Summary report: N

DRIVER SHAFT, T10 HEXALOBE, CANNULATED

MDR report key: 17112354 · Received June 12, 2023

Report

Report Number: 1220246-2023-06906
Event Type: Malfunction
Date Received: June 12, 2023
Date of Event: May 19, 2023
Report Date: October 30, 2024
Manufacturer: ARTHREX, INC.
Product Code: LXH
UDI-DI: 00888867046115
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

COMPLAINT IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED AR-8737-16 HAD BOTH TWISTED AND BROKEN. NO FRAGMENTS WERE RETURNED FOR INSPECTION. ALSO, IT WAS NOTED THAT THE PAINT GROOVE OF BOTH COLORS IS COMING OFF. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE.

Description of Event or Problem · 0

ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-16 AND AN AR-8737-25 , 2.4 AND 3.0 CANNULATED DRIVERS BROKE DURING A CASE DUE TO WEAR AND TEAR. PATIENT WAS NOT AFFECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
587589	DRIVER SHAFT, T10 HEXALOBE, CANNULATED	ORTHOPEDIC MANUAL SURG INSTR	LXH	ARTHREX, INC.	DRIVER SHAFT, T10 HEXALOBE, CANNULATED	6791145	00888867046115

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown