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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 Failure to Power Up (1476); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
Complaint internal reference: (b)(4). Smith & nephew is submitting this report pursuant to the provisions of 21 c. F. R. Part 803. This report may be based upon information which smith / nephew has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, smith / nephew, or its employees, that the report constitutes an admission that the device, smith / nephew or its employees caused or contributed to the potential event described in this report. The reported device, intended for use 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 product and observed no issue. A functional evaluation revealed a hand piece sensor fault. 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 concluded this was a repeat issue. The complaint was confirmed and the root cause has been associated with an electrical component failure. Factors that could have contributed to the reported event include a failure of the reed switch or damage on the hall board which may contribute to a short circuit.
 
Event Description
It was reported that the motor drive unit was not functioning properly, when the device was plugged in to the console and activated, it did not actually activate the blade/burr and work. It is unknown whether there was a back up available or delay in the case and if the event happened during surgery. No patient injuries were reported. Results of investigation have concluded that the device had a handpiece sensor fault and this is 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
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11159640
MDR Text Key226656090
Report Number1643264-2021-00123
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200616
Device Catalogue Number72200616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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