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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 Circuit Failure (1089)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2018
Event Type  malfunction  
Event Description
It was reported that when plugging mdu into shaver box, it read short circuit. A backup device was available to complete the procedure with no delay or patient injuries.
 
Manufacturer Narrative
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. Mdu failed functional tests with short circuit 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 a large kink was observed near strain relief. 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. Device returned for evaluation. Device evaluated by the manufacturer.
 
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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
MDR Report Key7591128
MDR Text Key111102771
Report Number1643264-2018-00447
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 07/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Yes
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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