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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC. ARTHREX DISPOSABLES KIT, TRANSTIBIA ACL WITHOUT BLADE PIN FIXATION SMOOTH

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ARTHREX INC. ARTHREX DISPOSABLES KIT, TRANSTIBIA ACL WITHOUT BLADE PIN FIXATION SMOOTH Back to Search Results
Model Number AR-1898S
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/25/2018
Event Type  Injury  
Event Description
A (b)(6) y/o female underwent left knee anterior cruciate ligament reconstruction to repair left acl tear. Arthrex transtibial guide pin utilized during procedure. Post op knee x-ray completed with finding of retained piece of the tibial guide pin. Pt required admission overnight as had eaten post operatively and need to wait an add'l 6 hrs prior to surgical removal. Pt underwent successful removal of guide pin on (b)(6) 2018 to prevent any complications related to the retention of guide pin.
 
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Brand NameARTHREX DISPOSABLES KIT, TRANSTIBIA ACL WITHOUT BLADE
Type of DevicePIN FIXATION SMOOTH
Manufacturer (Section D)
ARTHREX INC.
naples FL 34108
MDR Report Key7673490
MDR Text Key113672658
Report NumberMW5078301
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAR-1898S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/09/2018 Patient Sequence Number: 1
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