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	Cyst(s) (1800); Pain (1994); Swelling (2091)
Date of Event	03/03/2020
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 a revision basal joint arthroplasty with suspensionplasty procedure was performed on a patient on (b)(6) 2020, where a mini tightrope, ar-8914ds, was explanted.No further details, additional information requested.Additional information provided (b)(6) 2020: the patient underwent a basal joint arthroplasty with suspensionplasty procedure on (b)(6) 2019.On (b)(6) 2019, the patient started to notice swelling over the (left thumb) basal joint area and experienced pain and popping.The patient does not recall any new specific trauma or injury.She has been using the brace provided by the surgeon, especially when she was lifting up kids for her work.The surgeon explained to the patient that the endobutton appeared to be lose and that is what is bothering her, causing a cyst.Per the surgeon, the thumb appears stable and there is a good gap at the basal joint area in spite of the tightrope not working.Surgeon suggested that the hardware be replaced.Revision surgery was perfomred on (b)(6) 2020.Operative report (b)(6) 2020: surgeon noted the following on the operative report: "at this stage, i noticed that the button was not at the base of the first metacarpal and had moved into the cmc joint.The button was then removed from that location.The knot was intact; however, the tightrope suture itself, the fiberwire, had broken and that is why the button was loose.At this stage, a second incision was made over the second metacarpal and the other part of the endobutton was identified over the second metacarpal and it was removed.After removal of the previous mini tightrope, i inspected the basal joint area and also the second metacarpal area to look for any sharp bony edges that could have caused the fiberwire to cut or break.However, i could not find any."' a second mini tightrope, ar-8914ds, lot: 10348533, exp: 7/31/2024, was implanted in its place.The revision procedure was performed by the same surgeon as the initial procedure.

• 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: 9883007
• Report Number: 1220246-2020-01766
• Device Sequence Number: 14167471
• Product Code: HTN
• UDI-Device Identifier: 00888867048881
• UDI-Public: 00888867048881
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
• Device Catalogue Number: AR-8914DS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/26/2020
• 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
• Patient Age: 52 YR