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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL, MDU, NON-HAND CNTL, ELITE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVC REPL, MDU, NON-HAND CNTL, ELITE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200617S
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
A visual inspection was performed on the exterior of product and no physical damage was observed. Mdu 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. The power cord's external covering had no visible physical damage. 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 the 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. : device returned for evaluation: device evaluated by the manufacturer: evaluation codes updated.
 
Event Description
It was reported that the mdu gets hot. No patient injury reported.
 
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Brand NameSVC REPL, MDU, NON-HAND CNTL, ELITE
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 78735
MDR Report Key7034838
MDR Text Key140938107
Report Number1643264-2017-01730
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200617S
Device Catalogue Number72200617S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
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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