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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMINI WITH HAND CONTROLS SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS POWERMINI WITH HAND CONTROLS SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72201500
Device Problems Overheating of Device (1437); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4). The reported device, intended for use in treatment, was received for evaluation. A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution. A complaint history review concluded this was a repeat issue. 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. No moisture was observed. A functional evaluation revealed a blade stall error. Overheating did not occur during testing. The complaint was confirmed and the root cause has been associated with a mechanical component failure. Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out. No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that, the gearbox of the "dyonics powermini shaver, with handcontrols" clicked, jammed and overheated. No case reported; therefore, there was no patient involvement.
 
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Brand NameDYONICS POWERMINI WITH HAND CONTROLS
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 Key12602702
MDR Text Key275882694
Report Number1643264-2021-02339
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72201500
Device Catalogue Number72201500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
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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