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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,EP-1 LONG, SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. FULL RADIUS BLADE,EP-1 LONG, SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205341
Device Problems Break (1069); Difficult to Remove (1528); Knife (3156)
Patient Problem No Information (3190)
Event Date 06/11/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

During a hip arthroscopy procedure it was reported that the blade broke inside of a patient. A second procedure was required to remove the piece(s). The date of the second procedure is unknown.

 
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Brand NameFULL RADIUS BLADE,EP-1 LONG,
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5303964
MDR Text Key33704599
Report Number1219602-2015-01256
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7205341
Device LOT Number50652806
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/16/2015 Patient Sequence Number: 1
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