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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 Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 04/26/2018
Event Type  Injury  
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.Device history record review revealed nothing relevant to this event.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported that the acl tightrope was implanted during a procedure on (b)(6) 2017.During rehabilitation, the tightrope broke.*no further details, additional information requested.Follow-up investigation: the tightrope broke about 6 months post-op.A revision surgery took place in the "end of (b)(6) or early (b)(6)".Since it seemed that the tendon had healed, nothing replaced the device.
 
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Brand Name
ACL TIGHTROPE RT W/ DEPLOYING SUTURE
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, adverse events
1370 creekside boulevard
naples, FL 34108-1945
8009337013
MDR Report Key7577705
MDR Text Key110450164
Report Number1220246-2018-00203
Device Sequence Number1
Product Code HTY
UDI-Device Identifier00888867095533
UDI-Public00888867095533
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/07/2018
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 Date05/01/2021
Device Catalogue NumberAR-1588RT-J
Device Lot Number10048458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/15/2018
Initial Date FDA Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
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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