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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 Problem Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
Event Type  Malfunction  
Event Description

It was reported that during knee arthroscopy surgery there was a short in the motor drive unit cord. No patient injuries or delay reported. Smith and nephew back-up device was available to complete the surgery. 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 Key10427115
MDR Text Key203686901
Report Number1643264-2020-00888
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2020
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
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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