MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE FT; WASHER, BOLT NUT

Catalog Number AR-8917DS

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 05/27/2015

Event Type  Injury  

Event Description

It was reported that upon insertion, the screw driver head broke off.The implant was inserted 3/4 of the way and was left a little proud.The implant could not be removed, nor could it be advanced.The surgeon left it in where it was as he felt it was secure.Bunionectomy procedure.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, 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 device was requested for evaluation but was not returned, 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.Device history record review revealed nothing relevant to this event.This type of event is typically caused by not inserting the implant co-axial to the pilot hole, prying/leveraging, the use of excessive force and/or improper bone prep.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.Discarded by the facility.

• Brand Name: MINI TIGHTROPE FT
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4840001
• MDR Text Key: 5938064
• Report Number: 1220246-2015-00153
• 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,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 1216065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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