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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED F/R,BL,4.5MM,SERIES 3000 /6 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BOXED F/R,BL,4.5MM,SERIES 3000 /6 SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7206011
Device Problem Metal Shedding Debris (1804)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/16/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that metal flakes shedded from the boxed f/r bl 4. 5mm series when activated. Metal flakes were reportedly shed inside of the patient and removed it by surgeon. There was no reported procedural delay. No patient injuries or complications were reported.

 
Manufacturer Narrative

Device investigation narrative - one 4. 5mm boxed full radius blade was returned for evaluation. Visual assessment of the blades showed shedding of the plated surface at the distal tip of the inner and outer blade. Functional inspection was performed and the inner blade rotated freely within the outer blades, no friction was felt in the unloaded condition. The device appears to have undergone excessive side loading during use causing a mis-alignment between the inner and outer blade that resulted in the shedding. Per the device ifu under precautions ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿. No root cause related to the manufacturing process can be established. Further investigation is not warranted at this time. (b)(4).

 
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Brand NameBOXED F/R,BL,4.5MM,SERIES 3000 /6
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 Key5784563
MDR Text Key49683080
Report Number1219602-2016-00371
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/05/2018
Device Catalogue Number7206011
Device LOT Number50581071
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/05/2016
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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