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

Model Number	MINI TIGHTROPE FT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
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 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 the patient underwent a procedure on (b)(6) 2019 where an arthrex mini tightrope, ar-8917ds, was implanted with no issue.After the case, the surgeon took an x-ray and it was found that the tip of the driver had broken off into the implant and was still attached.A second surgery was performed and the broken driver tip was removed still fused to the screw.They were both removed with no incident.A second screw was opened and used to complete the case.Additional information provided (b)(6) 2019: the arthrex rep that was present during the lisfranc ligament repair and confirmed that a second surgery was not necessary as previously reported.The implant was removed during the same surgery.It is not clear to the surgeon when the driver broke.The surgeon noticed that it was broken at the time of the x-ray.Additional information provided (b)(6) 2019: the surgeon reopened incisions to remove the implant; he did not have to create any new incisions.
Additional Manufacturer Narrative
Complaint confirmed, a section of the drive feature broke off.The fracture was most likely 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: 8535437
• Report Number: 1220246-2019-01060
• Device Sequence Number: 312008
• 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: 07/31/2023
• Device Model Number: MINI TIGHTROPE FT
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 10232953
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/22/2019
• 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
• Outcome Attributed to Adverse Event: Other