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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 01/01/1901
Event Type  malfunction  
Event Description
It was reported that there was domino-effect issue with boxes and hand pieces had a short circuit. It is unknown whether the event happened during surgery and if there was patient involvement. Unknown if there was a delay, if backup was available and how the issue was resolved. No patient injury or other complications were reported.
 
Manufacturer Narrative
The device was received for evaluation. There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Complaint of short circuit could not be reproduced. Product passed functional and high speed testing (100-10,000 rpms) for 5 minutes each in forward, reverse and oscillate directions. Unit passed functional tests on the dyonics power, dii and dii eip test control units with and without footswitch. Short circuit did not occur during functional testing. The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process. 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 Key8243585
MDR Text Key133070572
Report Number1643264-2019-00041
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2019
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 Manufacturer01/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2019
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 Unkown

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