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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW ARTHROSCOPE

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SMITH AND NEPHEW ARTHROSCOPE Back to Search Results
Catalog Number 72201671
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/14/2015
Event Type  malfunction  
Event Description
Piece from the tip of arthroscope broke off during procedure and lodged in patient's right hip joint.
 
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Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH AND NEPHEW
andover MA
MDR Report Key5416633
MDR Text Key37728277
Report NumberMW5060035
Device Sequence Number1
Product Code HRX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72201671
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/03/2016 Patient Sequence Number: 1
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