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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,5.5MM DSPL. EP-1 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. FULL RADIUS BLADE,5.5MM DSPL. EP-1 SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205307
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/14/2018
Event Type  Malfunction  
Event Description

It was reported that during the surgery metal blade fragments were lost in the patient while the bone was being scrapped. No patient injury was reported. Back-up device was available.

 
Manufacturer Narrative

Examination was not possible, as the device has not been returned. The investigation could not draw any conclusions about the reported event without the return of the device.

 
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Brand NameFULL RADIUS BLADE,5.5MM DSPL. 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
jim
arthrocare corporation
7000 west william cannon drive
austin, TX 78735
MDR Report Key7616638
MDR Text Key111940206
Report Number1219602-2018-00766
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/15/2017
Device MODEL Number7205307
Device Catalogue Number7205307
Device LOT Number50697402
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 Received07/31/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/15/2017
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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