FDA Adverse Event Malfunction Summary report: N

K-LESS T-ROPE W/DRV, SYN REPR, SS

MDR report key: 19126889 · Received April 17, 2024

Report

Report Number: 1220246-2024-02093
Event Type: Malfunction
Date Received: April 17, 2024
Date of Event: May 24, 2021
Report Date: April 17, 2024
Manufacturer: ARTHREX, INC.
Product Code: HTN
UDI-DI: 00888867281615
PMA / PMN Number: K043248
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

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 EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING.

Description of Event or Problem · 0

IT WAS REPORTED DURING AN ANKLE FRACTURE CASE, THE TENSIONING SUTURE ON THE FIRST AR-8925SS SNAPPED BEFORE THE SURGEON APPLIED PRESSURE AND IT HAD TO BE CUT OUT. THE SECOND AR-8925SS SNAPPED AT THE END AS THE SURGEON WAS APPLYING FINAL TENSION, BUT THE SURGEON WAS ABLE TO SALVAGE IT. ADDITIONAL INFORMATION RECEIVED ON 6/4/2021: THE REP REPORTED FOR THE FIRST OF TWO DEVICES, SUTURES NEEDED TO BE CUT SO THE DEVICE COULD BE FULLY REMOVED FROM THE BONE TUNNEL. THE REP BELIEVES A SYNDESMOTIC SCREW WAS USED FOR FIXATION INSTEAD. THE SECOND OF TWO DEVICES FAILED AT FINAL TENSIONING, AND THIS DEVICE WAS STILL ABLE TO BE SALVAGED/USED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1022887	K-LESS T-ROPE W/DRV, SYN REPR, SS	WASHER, BOLT, NUT	HTN	ARTHREX, INC.	K-LESS T-ROPE W/DRV, SYN REPR, SS	12266615	00888867281615

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown