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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
Catalog Number 72200616
Device Problem Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2019
Event Type  Malfunction  
Event Description

It was reported that at starting of shoulder procedure the device turned on and off by itself. A backup device was available to complete the procedure with no delay or patient injuries.

 
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. Complaint of mdu running by itself was confirmed. Product failed functional testing with intermittent running of motor when housing was shaken. Cause of intermittent motor activation without using the buttons is an intermittent left button. Defective button switch is making the button intermittently stick in the ¿on¿ position. Button switch has a small burr inside causing the keeper switch to intermittently stick when housing is shaken. The complaint was confirmed and a root cause has been associated with a manufacturing operator error. A review of the service device history records show that a prior repair was performed for the same failure mode on (b)(4) of 2017 and apparently was not successful in resolving the problem. There are no indications to suggest that the product did not meet manufacturing specification upon release to distribution.

 
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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 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8401734
MDR Text Key138384052
Report Number1643264-2019-00183
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200616
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2019
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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