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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG, ABS; SMOOTH FIXATION PIN

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ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG, ABS; SMOOTH FIXATION PIN Back to Search Results
Model Number ACL TIGHTROPE WITH FIBERTAG, ABS
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2024
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
 
Event Description
It was reported that during a knee surgery the needle tore off from the suture.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
 
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Brand Name
ACL TIGHTROPE WITH FIBERTAG, ABS
Type of Device
SMOOTH FIXATION PIN
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
jared engle
8009337001
MDR Report Key18809166
MDR Text Key336640008
Report Number1220246-2024-01212
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K110123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberACL TIGHTROPE WITH FIBERTAG, ABS
Device Catalogue NumberAR-1588TNT
Device Lot Number15134402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2024
Initial Date Manufacturer Received 02/13/2024
Initial Date FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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