MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE FT; WASHER, BOLT NUT

Model Number	MINI TIGHTROPE FT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a lisfranc ligament repair procedure, while screwing in the implant, the tip of the driver included in the ar-8917ds, lot number 10198981, broke off into the patient.The surgeon did not retrieve the broken pieces, thinking that there was no problem.Before the operation, the risk of tip breaking was explained.During the operation, the surgeon used 3 fingers to hold the driver and inserted it.Surgeon stated that the patient's bony tissue was hard.Additional information provided 4/1/2019: the tip of the driver broke off into the implant.The surgeon used the same driver to complete the case.No x-rays were taken.
Additional Manufacturer Narrative
Complaint confirmed, a section of the drive feature broke off.Per sem analysis, the fracture was most likely ductile and caused by a mechanical load during use.This may be seen if the device is misaligned, improper bone prep and/or pried and leveraged during implant insertion.

• Brand Name: MINI TIGHTROPE FT
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8500687
• Report Number: 1220246-2019-01028
• Device Sequence Number: 2798629
• Product Code: HTN
• UDI-Device Identifier: 00888867048959
• UDI-Public: 00888867048959
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: MINI TIGHTROPE FT
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 10198981
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1