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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT W/ DEPLOYING SUTURE PIN, FIXATION, SMOOTH

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ARTHREX, INC. ACL TIGHTROPE RT W/ DEPLOYING SUTURE PIN, FIXATION, SMOOTH Back to Search Results
Catalog Number AR-1588RT-J
Device Problems Material Rupture; Device Slipped
Event Date 07/21/2015
Event Type  Injury  
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. 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 nicking the suture with another instrument, fraying from sharp edges of the bone tunnel and/or applying excessive force when shortening the suture strands. The directions for use for the device states: "excessive force on the shortening suture strands may break the strands and impair ability to fully seat the implant". This is the second 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. Facility will not release the device.

 
Event Description

It was reported that there was an acl reconstruction operation. As surgeon stretched patient's leg, he heard a sound and he took an mri and ct. The mri and ct showed that the graft became loose. He decided to do a second surgery and he found that tightrope was ruptured. The second surgery was successful.

 
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. Complaint confirmed. The evaluation revealed that the returned splice loop strand's tip appeared to have been cut on one returned suture and frayed on the other. Two buttons were returned. New braided uhmwpe white suture was used to test the buttons for sharp edges and breakage. One button had no visual anomalies, did not break the sutures and no sharp edges were observed. The other button received was severely damaged. Scratches/dents/nicks were present which appeared to have been caused by user mechanical damage, such as hitting the device with another device, causing the suture to fray during function testing. 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

It was reported that there was an acl reconstruction operation. As surgeon stretched patient's leg, he heard a sound and he took an mri and ct. The mri and ct showed that the graft became loose. He decided to do a second surgery and he found that tightrope was ruptured. The second surgery was successful.

 
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Brand NameACL TIGHTROPE RT W/ DEPLOYING SUTURE
Type of DevicePIN, 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 Key5038769
Report Number1220246-2015-00223
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 11/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2019
Device Catalogue NumberAR-1588RT-J
Device LOT Number1189809
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/28/2015 Patient Sequence Number: 1
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