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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); Intermittent Energy Output (4025)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: case (b)(4).
 
Event Description
It was reported that, during procedure, the mdu handpiece was overheating and stopped working whenever it got hot.The procedure was finished with a non significant delay using a smith and nephew back up device.No further complications were reported.
 
Manufacturer Narrative
H10: internal complaint reference:(b)(4).H2: additional information in b5 (description) and d4 (serial number).
 
Event Description
It was reported that, during an acl procedure, the mdu handpiece was overheating and stopped working whenever it got hot.The procedure was finished with a non-significant delay using a smith and nephew back up device.No further complications were reported.
 
Manufacturer Narrative
Internal complaint reference (b)(4).The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.A review of the customer provided image confirmed the product part number and serial number.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 event.A risk management review found that the reported failure of overheating was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of risk management files found that there was insufficient information to tie the reported complaint of stopped working to specific line items.The complaint was not confirmed.Factors which can contribute to overheating include a blade stall condition that will result in increased current draw from the control unit which will heat the motor and hand piece housing.This can be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
 
Manufacturer Narrative
Internal complaint reference (b)(4).The reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection found no issues.A functional evaluation revealed a blade stall error and overheating of the power cord.Further evaluation revealed a defective power cord.It was determined that the power cord has shorted internal wiring.A review of customer provided image confirmed the product part number and serial number.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 found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed, and the root cause was associated with a short in the 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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.Several corrective actions were taken to reduce the occurrence of this failure.No further actions are required at this time.
 
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Brand Name
MOTOR DRIVE UNIT HAND CNTRL PWRMX EL
Type of Device
SAW, 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 Key12928963
MDR Text Key282730280
Report Number1643264-2021-02452
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010555472
UDI-Public03596010555472
Combination Product (y/n)N
Reporter Country CodeNP
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 10/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72200616
Device Catalogue Number72200616
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2021
Initial Date FDA Received12/03/2021
Supplement Dates Manufacturer Received12/05/2021
02/10/2022
10/26/2022
Supplement Dates FDA Received12/22/2021
02/11/2022
10/27/2022
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 Unknown
Patient Sequence Number1
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