MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM; WASHER, BOLT NUT

Model Number	IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
Health Effect - Clinical Codes	Rash (2033); Swelling (2091)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested for evaluation but was not returned.Device remains in patient, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The typical cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.
Event or Problem Description
It was reported that the patient underwent a bunionectomy on her right foot on (b)(6) 2017 where a mini tightrope, ar-8914ds, was implanted.About two months post-op, in (b)(6), the patient began to experience rash-like symptoms beginning at the top of her foot near the incision site.She went to see her surgeon who prescribed her a topical ointment.The ointment relieved the symptoms but did not cure the rash.She then went to the er where she was prescribed another topical ointment.This prescription also only relieved the symptoms.The patient has also seen a dermatologist and an allergist and has not been able to cure the rash that has now turned into blisters.

• Brand Name: IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7806010
• Report Number: 1220246-2018-00606
• Device Sequence Number: 11147017
• Product Code: HTN
• UDI-Device Identifier: 00888867048881
• UDI-Public: 00888867048881
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
• Device Catalogue Number: AR-8914DS
• Device Lot Number: 10046953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/22/2018
• 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