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	06/04/2018
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 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 tightrope fixation procedure, upon insertion of the anchor, the screw driver head became stripped.The anchor could not be removed, nor could it be advanced.The surgeon then opened a second kit in an attempt to use its driver to insert the anchor further into the bone or back it out of the bone but the attempt was unsuccessful.He shaved the bone around the anchor to retrieve it.The surgeon used a cannulated cancellous screw to complete the case with no adverse effect to the patient.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed that both ar-8917ds drivers had been stripped prior to receipt for investigation.The mini tightrope anchors associated with each driver had broken off at the proximal hex, and chipping/metal damage was observed across the od of the second anchor, proximal to the breakage point.This type of event is most likely caused by not inserting the implant co-axial to the pilot hole, prying/leveraging, the use of excessive force and/or by improper bone preparation.

• 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: 7614179
• Report Number: 1220246-2018-00508
• Device Sequence Number: 19271141
• 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): 11/06/2018

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: No Information
• Device Expiration Date: 11/30/2022
• Device Model Number: MINI TIGHTROPE FT
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 10177512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 11/06/2018
• 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