FDA Adverse Event Malfunction Summary report: N

SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM

MDR report key: 19003699 · Received March 29, 2024

Report

Report Number: 1220246-2024-01729
Event Type: Malfunction
Date Received: March 29, 2024
Date of Event: February 10, 2022
Report Date: March 29, 2024
Manufacturer: ARTHREX, INC.
Product Code: MAI
UDI-DI: 00888867024229
PMA / PMN Number: K180594
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION: 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 MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING A SHOULDER STABILISATION SURGERY THE SUTURE SNAPPED ON TENSIONING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT 22-FEB-2022: THEY DIDN'T USE ANOTHER ANCHOR IN THAT POSITION AS THE SPACE WAS LIMITED, THEY RELIED ON THE OTHERS. THE ANCHOR REMAINS THERE IN PLACE, BUT WITH NO SUTURES. NO SWITCH IN TECH, JUST RELIED ON OTHER ANCHORS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2253863	SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM	NON-DEGRADABLE FIXATN FASTENER	MAI	ARTHREX, INC.	SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM	13667407	00888867024229

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown