MOTOR DRIVE UNIT HAND CNTRL PWRMX EL 72200616

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for MOTOR DRIVE UNIT HAND CNTRL PWRMX EL 72200616 manufactured by Smith & Nephew, Inc..

Event Text Entries

[186617560] It was reported that during knee surgery, the powermax elite shaver (handcontrols) overheated. The procedure was successfully completed without delay using a back-up device. No patient injuries or other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1643264-2020-00188
MDR Report Key9908454
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street76 S. MERIDIAN AVE.
Manufacturer CityOKLAHOMA CITY OK 731076512
Manufacturer CountryUS
Manufacturer Postal Code731076512
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMOTOR DRIVE UNIT HAND CNTRL PWRMX EL
Generic NameSAW, POWERED, AND ACCESSORIES
Product CodeHAB
Date Received2020-03-31
Returned To Mfg2020-03-20
Model Number72200616
Catalog Number72200616
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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