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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 Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2017
Event Type  malfunction  
Event Description
It was reported that during or setup the mdu overheated and stopped working. No injuries or complications were noted as a result. A backup mdu was used to perform the procedure without incident.
 
Manufacturer Narrative
The reported complaint of overheating and noise could not be confirmed. Product did not generate excessive noise or overheat during functional testing. Unit was tested at speed settings between 100 and 10,000 rpm¿s in forward and reverse for 5 minutes each. Also oscillate for 5 minutes in highest setting (9). Product was tested on a known good dyonics power, dii, and dii eip control units with and without footswitch. At no time did mdu overheat or become noisy. All functions perform as expected. No problem found. A review of the device history record was performed which confirmed no inconsistencies.
 
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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 drive
austin, TX 78735
MDR Report Key6598786
MDR Text Key76385232
Report Number1643264-2017-00300
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 06/27/2017
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 Manufacturer06/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2015
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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