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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 Electrical Shorting (2926)
Patient Problem No Information (3190)
Event Date 06/25/2019
Event Type  malfunction  
Event Description
It was reported that the device had a short circuit.It is unknown whether the event happened during surgery and if there was a patient involvement.
 
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.Mdu failed functional tests with hand piece overload when power cord was bent or twisted.Power cord assembly 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 Name
MOTOR DRIVE UNIT HAND CNTRL PWRMX EL
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8762782
MDR Text Key150136966
Report Number1643264-2019-00448
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010555472
UDI-Public03596010555472
Combination Product (y/n)N
PMA/PMN Number
EXEMPT.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2019
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 Manufacturer07/25/2019
Date Manufacturer Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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