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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
Model Number 72200616S
Device Problem Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/1901
Event Type  Malfunction  
Manufacturer Narrative

Initial reporter foreign zip code: (b)(6).

 
Event Description

It was reported that the mdu was hot. No patient injury.

 
Manufacturer Narrative

The device was received for evaluation. A visual inspection was performed on the exterior of product and no physical damage was observed. There was a relationship found between the returned device and the reported incident. (b)(6) failed functional tests with motor stall error and overheating when power cord was bent near strain relief. Power cord assembly grew warm during testing. After troubleshooting, the cause of motor stall and overheating was observed to be a defective power cord assembly. A visual inspection was performed on the power cords external covering and no physical damage was observed. It was determined that the power cord has shorted or open internal wiring. Motor and hall board were tested and passed functional testing. The complaint investigation has concluded that this unit has succumbed to physical damage to power cord. Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

 
Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed. A relationship, if any, between the subject device and the reported event could not be determined. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

 
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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 west william cannon drive
austin, TX 
MDR Report Key7150445
MDR Text Key96059722
Report Number1643264-2017-01859
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72200616S
Device Catalogue Number72200616S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
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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