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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT; PIN, FIXATION, SMOOTH

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ARTHREX, INC. ACL TIGHTROPE RT; PIN, FIXATION, SMOOTH Back to Search Results
Model Number ACL TIGHTROPE RT
Device Problem Break (1069)
Patient Problem Tissue Damage (2104)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that during an acl reconstruction procedure, after the button was deployed into the lateral femoral cortex, the surgeon started to tension the suture and the suture broke immediately.There was never any instrument clamp on the suture during the graft preparation process or while passing the graft through tunnels.The surgeon had to pull the graft back out of the tunnel and make a bigger incision then pull all the acl tightropert through the lateral femoral cortex.
 
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Brand Name
ACL TIGHTROPE RT
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
8009337001
MDR Report Key8228362
MDR Text Key132485860
Report Number1220246-2019-00838
Device Sequence Number1
Product Code HTY
UDI-Device Identifier00888867019553
UDI-Public00888867019553
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K112990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 01/08/2019
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 Date03/31/2023
Device Model NumberACL TIGHTROPE RT
Device Catalogue NumberAR-1588RT
Device Lot Number10206464
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/20/2018
Initial Date FDA Received01/08/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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