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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 05/05/2017
Event Type  malfunction  
Event Description
It was reported the hand piece motor stalled. There was no backup device available for use.
 
Manufacturer Narrative
The complaint of motor stall when engaged was confirmed. Mdu failed for hand piece motor stall error. Cause of errors is a defective motor. Motor tac #2 & #3 shorted out. No containment or corrective actions are recommended at this time.
 
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Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w. william cannon
austin, TX 78735
MDR Report Key6597414
MDR Text Key76268876
Report Number1643264-2017-00295
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 07/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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