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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CURVED INCISOR PLUS ELITE BL,4.5MM, SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. CURVED INCISOR PLUS ELITE BL,4.5MM, SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200036
Device Problem Metal Shedding Debris (1804)
Patient Problem Test Result (2695)
Event Date 12/21/2017
Event Type  Malfunction  
Event Description

It was reported that dr. (b)(6) has been experiencing metal shavings, from the shaver, in the joint during his cases. He has seen metal shavings. Generally it happens in his acl and shoulder cases.

 
Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting. The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event. This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

 
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Brand NameCURVED INCISOR PLUS ELITE BL,4.5MM,
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
MDR Report Key7138886
MDR Text Key95735314
Report Number1219602-2017-01573
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,USER F
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72200036
Device Catalogue Number72200036
Device LOT Number50673912
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/11/2017
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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