• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG; SMOOTH FIXATION PIN Back to Search Results
Model Number ACL TIGHTROPE WITH FIBERTAG
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
It was reported that during an anterior cruciate ligament surgery the needle got detached from the device.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACL TIGHTROPE WITH FIBERTAG
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 Key18806360
MDR Text Key336580326
Report Number1220246-2024-01198
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K112990
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
Device Catalogue NumberAR-1588RTT
Device Lot Number15142808
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/12/2024
Initial Date FDA Received02/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-