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

Catalog Number AR-8919DS

Device Problems Break (1069); Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 04/15/2015

Event Type  Injury  

Manufacturer Narrative

Patient demographics (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.Lot number was not provided so device history record review cannot be performed.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.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.The most likely cause of this type of event is patient non-compliance with the post-op protocol.The product directions for use states: post-operatively, until healing is complete, the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.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.Facility will not release the device.

Event Description

It was originally reported that a cmc mini tightrope was used for a right thumb procedure on (b)(6) 2013.The suture of the device broke and a revision surgery was performed on an unknown date.Another revision surgery was performed on (b)(6) 2015.Follow-up investigation: patient had a surgery on (b)(6) 2013 during which the following procedures were performed: trapezial resection interposition arthroplasty, right wrist and tendon transfer, suspensionplasty, right thumb.On (b)(6) 2013 patient underwent a revision suspensionplasty with mini tightrope anchor (details unknown).On (b)(6) 2015 patient underwent a third surgery for revision suspensionplasty, right thumb.The suture was found to have ruptured between the two endo buttons likely at the volar surface of the thumb metacarpal suture tunnel.During this (b)(6) 2015 revision, two mini tightrope anchors were placed and sutured with distraction on the thumb.

• Brand Name: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5081654
• MDR Text Key: 25994806
• Report Number: 1220246-2015-00244
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-8919DS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR