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	04/28/2020
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 mini tightrope, ar-8917ds, was being used in a lisfrac joint dislocation repair procedure.During use, the suture broke.Furthermore, when attempting to remove the remaining screw, it was confirmed that the tip of the inserter was broken and the broken piece was in the head of the screw.Additional information requested.Additional information provided 05/05/2020: the screw was left in the patient with the tip of the driver lodged in the head of the screw.There are no x-rays available and the inserter will be returned for evaluation.
Additional Manufacturer Narrative
The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that the shaft of the device fractured in half toward the distal end.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon 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: 10074777
• Report Number: 1220246-2020-01848
• Device Sequence Number: 2900282
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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 Model Number: MINI TIGHTROPE FT
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 10414138
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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