MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,CMC MINI T-ROPE,1.1 MM; WASHER, BOLT NUT

Model Number	IMPL SYS,CMC MINI T-ROPE,1.1 MM
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Date of Event	05/30/2019
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.It was reported that the patient has the device.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 relative that on (b)(6) 2018 the patient underwent a trapeziectomy during which an arthrex, ar-8919ds cmc mini-tightrope, was implanted.Prior to the surgery she had experienced intermittent pain but since the surgery the pain has been a constant chronic pain.In addition, since surgery the patient¿s usage of her hand has decreased with only about 50% mobility which is much less than prior to the surgery.In addition, the outline shape of the implant device can be seen pressing against the skin.Caller requested material composition of the device which has been provided to the patient.Caller and patient were also seeking surgeons in their area that are experienced with removal of the implant.Additional information obtained 3/21/2019: patient has had several consultations and it is reported the consensus is that the ar-8919ds, mini-tightrope, needs to be removed.Patient continues to have quite a bit of pain where the buttons are, especially the one on the index finger where the button is visible just under the skin.It has also been reported that the doctors indicated there is a possibility that patient might be having a reaction to any one of the device component materials.At time of update the patient has not chosen a surgeon to perform the surgery.Additional information obtained 6/17/2019: patient underwent a revision surgery (b)(6) 2019.Along with removing the ar-8919ds buttons, the surgeon also transplanted a tendon and repositioned her thumb, which she had not been able to extend beyond 1 inch.He also operated on the knuckles on top of her hand because they had become completely frozen.The surgery was reported to have been very extensive.Patient started therapy within one week.So far, she has been able to make a fist which she had not been able to do for the past year.Her thumb will remain immobile for another month at which time her therapy will include regaining use of her thumb.Additional information obtained 6/18/2019: patient has the explanted buttons in her possession.

• Brand Name: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8739120
• Report Number: 1220246-2019-01177
• Device Sequence Number: 2637711
• Product Code: HTN
• UDI-Device Identifier: 00888867048966
• UDI-Public: 00888867048966
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 12/31/2021
• Device Model Number: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Device Catalogue Number: AR-8919DS
• Device Lot Number: 10085425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/27/2019
• 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