FDA Adverse Event Malfunction Summary report: N

FIBERTAK BICEPS IMPLANT SET

MDR report key: 19536595 · Received June 14, 2024

Report

Report Number: 1220246-2024-05692
Event Type: Malfunction
Date Received: June 14, 2024
Date of Event: February 17, 2023
Report Date: June 13, 2024
Manufacturer: ARTHREX, INC.
Product Code: MBI
UDI-DI: 00888867305427
PMA / PMN Number: K181769
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, 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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE DEVICE DURING USE.

Description of Event or Problem · 0

ON 2/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM, WERE BEING USED FOR A PROXIMAL BICEPS PROCEDURE ON (B)(6) 2023. SURGEON DRILLED WITH STANDARD DRILLING TECHNIQUE WHEN THE DRILL BIT MELTED THE DRILL GUIDE STALLING THE DRILL BIT. A NEW KIT WITH THE SAME LOT NUMBER WAS OPENED AND THE NEW DRILL STALLED AGAIN AS WELL AFTER DRILLING THE FULL DEPTH NEEDED. SURGEON MANUALLY REMOVED THE DRILL FROM THE GUIDE AND INSERTED THE ANCHOR LIKE NORMAL. AND PROCEEDED THE CASE UNDER NORMAL PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
393901	FIBERTAK BICEPS IMPLANT SET	NON-DEGRADABLE FIXATN FASTENER	MBI	ARTHREX, INC.	FIBERTAK BICEPS IMPLANT SET	15024102	00888867305427

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown