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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 5.5MM FULL RADIUS PLATINUM SERIES SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. 5.5MM FULL RADIUS PLATINUM SERIES SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72203522
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/25/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that, during a knee arthroscopy, the blade was shooting debris into the joint. It is unknown if the debris was removed from the knee. It is unknown if a back-up device was available to complete the procedure. It is unknown how long the surgery was delayed as consequence of the alleged malfunction. The patient was not stated to be injured.

 
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Brand Name5.5MM FULL RADIUS PLATINUM SERIES
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8532072
MDR Text Key142617955
Report Number1219602-2019-00438
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72203522
Device LOT Number50770101
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 Received08/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/11/2018
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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