MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; PIN, FIXATION, SMOOTH

Catalog Number AR-1588TB-1

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 02/23/2015

Event Type  Injury  

Event Description

It was originally reported that the button could not seat on the cortex and entered into bone hole.Another product was used to complete the case.Follow-up investigation: there is no information about whether the surgeon could get the button to flip and seat on the cortex or not there was no information about bone condition, final shape of bone hole, actual procedure for the operation he did.The surgeon used plate and screws as a substitute for the button.The plate and screws are from another manufacturer.

Manufacturer Narrative

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.Device history record review revealed nothing relevant to this event.The evaluation of the device revealed nothing relevant to the event.The cause of the event cannot be determined.If additional relevant information is obtained from the investigation, a follow-up report will be submitted.This is the first complaint of this type for this part/lot combination.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 4666510
• MDR Text Key: 5625295
• Report Number: 1220246-2015-00084
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/12/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 1253037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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