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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616
Device Problem Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2019
Event Type  Malfunction  
Event Description

It was reported that the motor was running sporadically, on and off on its own. No patient injury or significant delay were reported. Back up device was available.

 
Manufacturer Narrative

The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the exterior of product and no physical damage was observed. The device failed functional tests with hand piece overload when power cord was bent or twisted. Power cord assembly and motor grew warm during testing. After troubleshooting, the cause of the 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 and/or opens 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.

 
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Brand NameMOTOR DRIVE UNIT HAND CNTRL PWRMX EL
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
5123585706
MDR Report Key8268396
MDR Text Key133777546
Report Number1643264-2019-00072
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200616
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
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

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