MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE IMP ONLY, SYN REPR ,TI; WASHER, BOLT NUT

Model Number K-LESS T-ROPE IMP ONLY, SYN REPR ,TI

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during an ankle fracture with syndesmosis repair surgery the device broke during tightening inside the patient.The broken off piece was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.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.

Manufacturer Narrative

Complaint confirmed.One unpackaged (b)(6) was received for investigation.Visual inspection identified that three distinct suture fragments were returned, with breakage observed at the distal ends of all three.No damage was noted to either of the buttons, nor the guide pin.The cause remains undetermined, although a probable cause can be attributed to user-applied excessive force during the tightening process.

• Brand Name: K-LESS T-ROPE IMP ONLY, SYN REPR ,TI
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12540237
• MDR Text Key: 274509408
• Report Number: 1220246-2021-03707
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867265608
• UDI-Public: 00888867265608
• Combination Product (y/n): N
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K-LESS T-ROPE IMP ONLY, SYN REPR ,TI
• Device Catalogue Number: AR-8924T
• Device Lot Number: 24608
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 10/28/2021
• Patient Sequence Number: 1