FDA Adverse Event Malfunction Summary report: N

REVERS LEVER-LOCKING BROACH HANDLE

MDR report key: 18164051 · Received November 17, 2023

Report

Report Number: 1220246-2023-08799
Event Type: Malfunction
Date Received: November 17, 2023
Date of Event: October 25, 2023
Report Date: January 15, 2024
Manufacturer: ARTHREX, INC.
Product Code: LXH
UDI-DI: 00888867290464
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

COMPLAINT IS CONFIRMED. VISUAL EVALUATION NOTED THAT ONE OF THE PINS WAS COMING OUT. CAPA-00306 WAS OPENED FOR THIS CONDITION. THE DISTAL TIP OF THE AR-9510-1-01 WAS BROKEN AND FOUND IN ONE OF THE HOLES OF THE BROACH HANDLE ASSEMBLY. THE EDGES AROUND THE DEVICE ARE DAMAGED. FUNCTIONAL TESTING NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. COMPLAINT SUPPLIER PROCESS - CAPA-00306 WAS OPENED FOR THIS CONDITION.

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.

Description of Event or Problem · 0

ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-01 VERSION ROD AND AN AR-9510-2 LEVER-LOCKING BROACH HANDLE BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1668167	REVERS LEVER-LOCKING BROACH HANDLE	ORTHOPEDIC MANUAL SURG INSTR	LXH	ARTHREX, INC.	REVERS LEVER-LOCKING BROACH HANDLE	052039	00888867290464

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown