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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 Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Date 08/31/2018
Event Type  Injury  
Manufacturer Narrative
The device was requested for evaluation but device disposition is unknown, therefore the complainant's event could not be verified.Device history record review revealed nothing relevant to this event; no issues were found with the sterilization of this lot.This device is supplied sterile.Based on the information provided, a definitive cause for the post-operative infection could not be determined.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.
 
Event Description
It was reported that the patient needed to have the devices removed post-op due to infection.Original dos (b)(6) 2018 for acl with hamstring autograft.Patient is (b)(6) male, who presented with pain, redness, swelling.A culture showed staph infection and the devices were removed.
 
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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 Key7873243
MDR Text Key120192615
Report Number1220246-2018-00640
Device Sequence Number1
Product Code HTY
UDI-Device Identifier00888867019553
UDI-Public00888867019553
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/13/2018
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 Date04/30/2023
Device Model NumberACL TIGHTROPE RT
Device Catalogue NumberAR-1588RT
Device Lot Number10209600
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/31/2018
Initial Date FDA Received09/13/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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