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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL. SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL. SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72203127
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a hip scope procedure, the device shed metal flakes into the patient. The surgeon flushed out the debris. There was no further need for this device in the procedure, so a backup device was not necessary. No patient injury or complications were reported.
 
Manufacturer Narrative
Heavy metal debridement was detected on the bushing as well as the proximal end of the inner burr with corresponding debridement on the outer sheath of the used burr. Additional unused burrs from the same batch number were inspected for any cosmetic/visual imperfections and were also functionally tested (unloaded condition); all parts met drawing specifications and functioned as designed. The device issue may be related to the operator's technique or use environment.
 
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Brand NameBURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
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
150 minuteman road
andover, MA 
5123585706
MDR Report Key5933061
MDR Text Key54587129
Report Number1219602-2016-00565
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/13/2019
Device Catalogue Number72203127
Device Lot Number50610926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2016
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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