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

Model Number	MINI TIGHTROPE REPAIR
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	09/20/2019
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 by a patient's relative that the patient had undergone a hallux varus procedure using an arthrex tightrope several months prior.The patient's relative indicated that the tightrope construct is believed to be broken.Patient is scheduled for a second surgery on (b)(6) 2019.Patient's relative did not have further details but provided contact information for the patient.Additional information obtained 10/15/2019: patient confirmed revision surgery took place on (b)(6) 2019.Patient is working on obtaining and providing medical records.Part number is still pending from the expected medical records.Patient expects to have all medical records by the end of (b)(6) 2019 after the final post-op appointment.The medical records indicate that the tightrope construct initially corrected a hallux varus deformity which was caused by the patient's two prior bunion surgeries.There is no evidence that the bunion returned.According to the records the tightrope lost correction which led to the great toe moving back to the prior varus position.Additional information obtained 1/9/2020: patient provided medical records which contain the arthrex device part number from the patient's (b)(6) 2018 procedure.The implant was an ar-8911ds, lot 19419, mini tightrope repair.Additional information obtained 1/16/2020: patient has reported that she has spoken with the surgeon who informed her that he accessed a different area and therefore the original tightrope suture is still in her foot and the original tightrope buttons remain in her bone.Nothing was explanted and the surgeon told the patient that he could remove them later on if needed.

• Brand Name: MINI TIGHTROPE REPAIR
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9667429
• Report Number: 1220246-2020-01646
• Device Sequence Number: 2800635
• Product Code: HTN
• UDI-Device Identifier: 00888867048805
• UDI-Public: 00888867048805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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 Expiration Date: 03/31/2023
• Device Model Number: MINI TIGHTROPE REPAIR
• Device Catalogue Number: AR-8911DS
• Device Lot Number: 19419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR