FDA Adverse Event Malfunction Summary report: N

BASEPLATE IMPACTOR, ASSEMBLY

MDR report key: 19416498 · Received May 29, 2024

Report

Report Number: 1220246-2024-04218
Event Type: Malfunction
Date Received: May 29, 2024
Date of Event: June 22, 2022
Report Date: May 29, 2024
Manufacturer: ARTHREX, INC.
Product Code: LXH
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, 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. COMPLAINT CONFIRMED. ONE UNPACKAGED AR-9165CDG BATCH NUMBER 051917 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE TRINITY GUIDE BASEPLATE ADAPTER HAD BROKEN OFF AT THE DISTAL END OF THE AR-9165CDG ASSEMBLY. NO FRAGMENTS WERE RETURNED FOR ANALYSIS. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS WEAR AND TEAR. SIGNS OF WEAR WERE OBSERVED IN THE DEVICE'S HANDLE AND SHAFT.

Description of Event or Problem · 0

ON 6/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9165CDG BASE PLATE IMPACTOR TWISTED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 6/30/2022: THIS WAS DISCOVERED DURING A RTS PROCEDURE AND COMPLETED WITH THE SAME INSTRUMENT. HOWEVER, THE WHITE BASEPLATE IMPACTORS HAD THE BLUE PLASTIC PIECE CRACKED THAT HOLDS THE BASEPLATE ON WITHOUT LETTING IT SLIP OFF. CASE WAS COMPLETED WITHOUT FURTHER ISSUE AND NOTHING BROKE INSIDE THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1884899	BASEPLATE IMPACTOR, ASSEMBLY	ORTHOPEDIC MANUAL SURG INSTR	LXH	ARTHREX, INC.	BASEPLATE IMPACTOR, ASSEMBLY	051917

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown