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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC.; ARTHROSCOPE, BLADE
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ARTHREX INC.; ARTHROSCOPE, BLADE Back to Search Results
Catalog Number AR8400RBE
Device Problems Metal Shedding Debris (1804); Defective Device (2588)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/20/2016
Event Type  malfunction  
Event Description
An arthrex anthroscopic shaver blade shed metal shards as it was being used to shave a knee during an orthopedic procedure.The physician performing the surgery was confident that the metal shards were not a result of the blade contacting the metal housing, but that the blade itself was defective and not able to handle the density of the bone.The metal shavings were noticed and the knee was thoroughly flushed.No metal was left in the patient.Per hospital, a return will be arranged.We will be asking for the failure analysis of this product to be shared with us.
 
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Type of Device
ARTHROSCOPE, BLADE
Manufacturer (Section D)
ARTHREX INC.
1370 creekside blvd.
naples FL 34108
MDR Report Key6166372
MDR Text Key62134426
Report Number6166372
Device Sequence Number0
Product Code NBH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberAR8400RBE
Device Lot Number1477573
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer11/10/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age48 YR
Patient Weight106
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