MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, BUTTON, 8 X 12 MM; PIN, FIXATION, SMOOTH

Catalog Number AR-1588RT

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/22/2015

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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The (b)(4) button was received for evaluation.The device met all material specifications as received.Function tested the returned device with a lab suture and no fraying or breakage was observed.The most likely cause of the complaint's event is the button not being properly seated on the cortical bone causing the device to slip into the medial portal.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.

Event Description

This was reported by the facility's risk manager, who forwarded the medwatch report that was filed by the facility: the patient underwent a repair of a torn acl on (b)(6) 2015.Patient had no pre-existing medical or surgical history.Patient was discharged the same day.Upon follow-up a week later, the surgeon noticed that the devices used to re-attach the acl were not in the appropriate position and not correctly attached.The patient was informed and required a subsequent surgery to repair.The revision surgery was performed on (b)(6) 2015.The femoral cortical button was found to be in the femoral tunnel and nearly extruded into the notch.The button required removal but the acl fixation was intact.Another button was put into place and the surgery completed successfully.This has been deemed to be a user technique.An arthrex representative was present during the procedure.Follow-up investigation: the acl tibial fixation was left intact.They were able to retrieve the femoral button and femoral end of the graft through the anterior medial portal, reloaded a tightrope (b)(4), through the intact graft, using the initial tight rope strands for shuttling.The tightrope strands were purposely cut during this shuttling technique and were destroyed and discarded.Button was kept and will be returned.

• Brand Name: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 5155137
• MDR Text Key: 28451973
• Report Number: 1220246-2015-00276
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Report Date: 09/23/2015

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: 04/01/2020
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 1264502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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
• Patient Age: 32 YR