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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
Model Number 72200616
Device Problems Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2020
Event Type  Malfunction  
Manufacturer Narrative

The reported device, used in treatment, 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. A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.

 
Event Description

It was reported that the buttons were stuck a few times during knee scope surgery. A backup device was available to complete the procedure with no delay or patient injuries. Results of investigation have concluded that this unit presented a short in the cable, which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9962364
MDR Text Key187759167
Report Number1643264-2020-00211
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/27/2020
Device MODEL Number72200616
Device Catalogue Number72200616
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/24/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2020
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 Unkown

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