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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAZORCUT BLADE,4.5 DISP,EP-1 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. RAZORCUT BLADE,4.5 DISP,EP-1 SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205318
Device Problem Metal Shedding Debris (1804)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/19/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the blade was shedding/flaking and as much as possible was irrigated out, but metal shavings were left in the patient's knee. A backup blade was available to complete the procedure. A delay of less than 30 minutes was reported with no patient impact associated with this event.

 
Manufacturer Narrative

Examination was not possible, as the device was not returned. The investigation was limited to the information provided. The investigation could not draw any conclusions about the reported event with the clinical details provided. A review of the device history record was performed which confirmed no inconsistencies. No further investigation is warranted at this time.

 
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Brand NameRAZORCUT BLADE,4.5 DISP,EP-1
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
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key6123185
MDR Text Key60931362
Report Number1219602-2016-01275
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2018
Device Catalogue Number7205318
Device LOT Number50724045
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 Received01/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2013
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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