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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); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a shoulder scope procedure, the motor drive unit was not working, it was getting hot. The procedure was successfully completed without delay using a back up device. No patient complications were reported.
 
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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 Key13204749
MDR Text Key283499499
Report Number1643264-2022-00013
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 User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
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 Manufacturer01/10/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/11/2022
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 Unkown

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