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

Catalog Number	AR-8920CDS
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Alteration In Body Temperature (2682); No Code Available (3191)
Date of Event	10/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.Device history record review revealed nothing relevant to this event.The cause of the event could not be determined from the information available and without device evaluation.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device remains in patient.
Event or Problem Description
It was reported that on (b)(6) 2016 the patient underwent a left knee procedure, reposition and stabilization of tibiofibular joint, in poland, where she resides, during which an arthrex, ar-8920cdc, knotless tightrope syndesmosis repair kit was used.Patient has been experiencing continued pain, redness, swelling and reduced flexing ability.Pain has been present in the inside (right) part of the knee but approximately 3 weeks prior to reporting patient began feeling pain on the outside (left) and inside of the kneecap too.Knee feels hot when touched.Patient has had three rehabilitation sessions of one week to ten days in length, where she would stay at the clinic, in addition to her regular outpatient therapy sessions.To date patient has had no relief from symptoms or improvement with flexion.Caller states surgeon told patient it is not an infection, although several other doctors and physical therapist have told patient it looks like an infection.It was reported surgeon informed patient she was not doing intensive enough therapy.Surgeon sent her to a therapist who patient states over-bent and over stretched her log so much she was unable to stand on it for about a week.Caller has requested the material composition of the device for possible allergy testing if an allergist determines testing is warranted.Material composition has been provided.

• Brand Name: TIGHTROPE SYNDESMOSIS REPAIR CANNULATED
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6484935
• Report Number: 1220246-2017-00115
• Device Sequence Number: 1289549
• Product Code: HTN
• UDI-Device Identifier: 00888867048980
• UDI-Public: 00888867048980
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/12/2016

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: 09/01/2019
• Device Catalogue Number: AR-8920CDS
• Device Lot Number: 12728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/12/2017
• 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