FDA Adverse Event Malfunction Summary report: N

IBAL UKA TIB BEA-RING TRL SZ 5 9MM

MDR report key: 19459328 · Received June 4, 2024

Report

Report Number: 1220246-2024-04836
Event Type: Malfunction
Date Received: June 4, 2024
Date of Event: February 2, 2023
Report Date: June 4, 2024
Manufacturer: ARTHREX, INC.
Product Code: HWT
UDI-DI: 00888867037694
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: 003

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 IS CONFIRMED. ONE UNPACKAGED AR-601-TBE9 TIBIAL BEARING TRIAL, SIZE 5, 9 MM SERIAL/BATCH NUMBER 6791216 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND SCRATCHES AND GOUGES ON THE FROM AND BACK OF THE DEVICE. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED. HOWEVER, A LIKELY REASON IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

Description of Event or Problem · 0

ON 2/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-601-TBE9 IBALANCE TIBIAL BEARING TRIAL IS WORN. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 2/3/2023: THIS WAS DISCOVERED DURING A UNI KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023. THE BEARING TRIAL WAS USED AS PART OF THE PROCEDURE AND AT THAT TIME IT WAS DISCOVERED THAT IT WAS TOO WORN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
150078	IBAL UKA TIB BEA-RING TRL SZ 5 9MM	ORTHOPEDIC MANUAL SURG INSTR	HWT	ARTHREX, INC.	IBAL UKA TIB BEA-RING TRL SZ 5 9MM	6791216	00888867037694

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown