FDA Adverse Event Malfunction Summary report: N

FIBERTAK BICEPS IMPLANT SET

MDR report key: 19578924 · Received June 20, 2024

Report

Report Number: 1220246-2024-06304
Event Type: Malfunction
Date Received: June 20, 2024
Date of Event: February 14, 2021
Report Date: June 20, 2024
Manufacturer: ARTHREX, INC.
Product Code: MBI
UDI-DI: 00888867305427
PMA / PMN Number: K181769
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 DEVICES WERE NOT RETURNED FOR EVALUATION; NO PICTURES WERE PROVIDED. BASED OFF THE INFORMATION PROVIDED; BONE DRILLED WITH 1.9 MM DRILL W/ SLEEVE AND THE PATIENT HAVING THICK CORTEX, THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE IS PATIENT-SPECIFIC AS THE BONE WAS RE-DRILLED THREE MORE TIMES.

Description of Event or Problem · 0

IT WAS REPORTED THAT ONE OF THE TWO 1.9 MM FIBERTAKS TO BE INSERTED INTO THE PROXIMAL ULNA DID NOT FULLY SEAT AND PULLED OUT OF THE BONE. THE BONE WAS RE-DRILLED DEEPER THREE ADDITIONAL TIMES AND THE FIBERTAK WAS SEATED. THIS PROCESS WAS REPEATED FOR THE SECOND FIBERTAK ANCHOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1511413	FIBERTAK BICEPS IMPLANT SET	NON-DEGRADABLE FIXATN FASTENER	MBI	ARTHREX, INC.	FIBERTAK BICEPS IMPLANT SET	UNK	00888867305427

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown