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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL,4.5MM FR ELITE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DISPOSABLE BL,4.5MM FR ELITE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7210499
Device Problems Particulates (1451); Metal Shedding Debris (1804)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2013
Event Type  Malfunction  
Manufacturer Narrative

Evaluation was not possible, as the device has not been returned (method code and results code). Due to this fact we are unable to determine what may have caused the user to experience the reported incident. A review of the device history record was performed which confirmed no inconsistencies (method code). In the event the samples are returned for evaluation the complaint will be reopened for additional investigation. (b)(4).

 
Event Description

During a knee scope procedure, it was reported that the blade was shedding in the joint. The metal particulate was removed from the joint space via suction. A backup device was available mitigating the five minute delay. No patient injury was reported. The device was disposed of so no product is available for analysis.

 
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Brand NameDISPOSABLE BL,4.5MM FR ELITE
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 Key4950671
MDR Text Key23138086
Report Number1219602-2015-00590
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
Reporter Occupation
Type of Report Initial
Report Date 07/29/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2017
Device Catalogue Number7210499
Device LOT Number50676832
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/07/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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