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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER,3.5,DSPL,BURR BOX/6 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ABRADER,3.5,DSPL,BURR BOX/6 SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 3819
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
One 3. 5 abrader burr was returned for evaluation. Visual assessment showed no abnormalities. Functional assessment was performed using a dyonics power shaver system control unit and a dyonics mini-motor handpiece. The burr operated as intended no variance in rpm was observed. This investigation could not identify any evidence of product contribution to the reported complaint. Further investigation is not required at this time.
 
Event Description
It was reported that while utilizing abrader 3. 5mm (c/n: (b)(4)), it was confirmed that the rotation speed was slowed even though the surgeon had set the maximum rpm setting. They couldn¿t resect the patient bone and the rotation of blade could be visible by the naked eye. They tried to reboot the control unit and reconnected the blade to the hand-piece, however the problem couldn¿t be resolved. They stopped to resect the patient bone and the procedure was finished only resection of the synovial tissue. There was a 10 minutes delay in the procedure. No patient injury reported.
 
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Brand NameABRADER,3.5,DSPL,BURR BOX/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
jim gonzales
7000 west william cannon drive
MDR Report Key7238834
MDR Text Key130374999
Report Number1219602-2018-00188
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/15/2022
Device Model Number3819
Device Catalogue Number3819
Device Lot Number50664367
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2017
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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