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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 Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2017
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed and no issues were noted. Product failed functional testing with hand piece error when inserted into mdu receptacle on test control unit. Cause of hand piece errors is a corroded forward button spring that was stuck in the ¿on¿ position. The complaint was confirmed and the root cause has been determined to be corrosion of the forward button assembly. Factors that could have contributed to the event include a buildup of corrosion/debris around the button assembly from cleaning chemical fluid ingression over time. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
Event Description
It was reported the mdu buttons were sticking. No patient injury or 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 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w. william cannon dr.
austin, TX 78735
MDR Report Key6897223
MDR Text Key139546576
Report Number1643264-2017-00576
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2017
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 Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
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 Reuse

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