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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12540237
• Report Number: 1220246-2021-03707
• Device Sequence Number: 11659109
• Product Code: HTN
• UDI-Device Identifier: 00888867265608
• UDI-Public: 00888867265608
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• 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 Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/28/2021
• Patient Sequence Number: 1