FDA Adverse Event Malfunction Summary report: N

IMPLANT SYSTEM, FIBERTAK BUTTON

MDR report key: 19359641 · Received May 21, 2024

Report

Report Number: 1220246-2024-03589
Event Type: Malfunction
Date Received: May 21, 2024
Date of Event: February 19, 2021
Report Date: May 21, 2024
Manufacturer: ARTHREX, INC.
Product Code: MBI
UDI-DI: 00888867305441
PMA / PMN Number: K191426
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: 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. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE REPORTED EVENT IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY PHOTOS PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING A PROXIMAL BICEP TENODESIS PROCEDURE, THE SURGEON PLACED THE DRILL GUIDE AT THE DESIRED LOCATION AND DRILLED THE FIRST CORTEX USING THE 2.6 MM DRILL. CHUCKING THE DRILL PIN AT THE BLACK LINE ALLOWS THE DRILL TO EXTEND 20 MM OUT OF THE DRILL GUIDE. THE AR-3680 DRILL WAS TOO SHORT FOR WHAT THE SURGEON NEEDED. THE SURGEON UN-CHUCKED THE AR-3680 AND WENT 5-7MM PAST THE LASER LINE AND THE CASE WAS COMPLETED WITHOUT ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
603722	IMPLANT SYSTEM, FIBERTAK BUTTON	NON-DEGRADABLE FIXATION FASTENER	MBI	ARTHREX, INC.	IMPLANT SYSTEM, FIBERTAK BUTTON	12484841	00888867305441

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown