FDA Adverse Event Malfunction Summary report: N

DBL LD DX FBR TK W/BLK, 0.9MM ST NDLS

MDR report key: 19330978 · Received May 16, 2024

Report

Report Number: 1220246-2024-03390
Event Type: Malfunction
Date Received: May 16, 2024
Date of Event: December 23, 2021
Report Date: May 16, 2024
Manufacturer: ARTHREX, INC.
Product Code: MBI
UDI-DI: 00888867377370
PMA / PMN Number: K172612
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, 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. 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 USER-APPLIED MECHANICAL FORCES DURING INSERTION. AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED.

Description of Event or Problem · 0

ON 12/22/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST-2 DX FIBERTAK WAS INSERTED THROUGH A 1.6MM PREPARED BONE TUNNEL AND AFTER IT PASSED THROUGH THE CORTEX, IT WAS DISCOVERED THAT THE FORKS ON THE INSERTER DEVICE HAD SHREDDED THE SUTURES BUNDLE. THIS WAS DISCOVERED DURING A REVISION OF A FAILED CMC INTERNAL BRACE ON (B)(6) 2021. SURGEON REDIRECTED TUNNELS AND USED A SINGLE-LOADED FIBERTAK DX TO COMPLETE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 12/23/2021. THERE WERE NOT ARTHREX DEVICES EXPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
474432	DBL LD DX FBR TK W/BLK, 0.9MM ST NDLS	NON-DEGRADABLE FIXATION FASTENER	MBI	ARTHREX, INC.	DBL LD DX FBR TK W/BLK, 0.9MM ST NDLS	14318767	00888867377370

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown