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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 ED72200616
Device Problems Overheating of Device (1437); Smoking (1585); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the dyonics generator alarm sounded.A short circuit error was present as well as smoke.The unit was unplugged immediately.The handpiece cord was hot to touch.No patient or user injury reported.This did not result in any delays.A backup device was available to complete the procedure.
 
Manufacturer Narrative
One service replacement powermax elite motor drive unit, part number (b)(4) was received on (b)(6) 2017 and confirmed to be serial number (b)(4).There was a relationship found between the returned device and the reported incident.Unit was powered on using the appropriate test equipment and it failed with "short circuit detected" error message and alarm.A kink was observed in the middle of the power cord and power cord grew hot.After troubleshooting, the cause of error was observed to be a defective power cord assembly.It was determined that the power cord has a shorted or open internal wire.Motor and hall board were tested and passed functional testing.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a crushing or shear force induced on the cord inconsistent with normal use.A review of the manufacturing records shows that this unit was released to distribution on or about december 5, 2014.No containment or corrective actions are recommended at this time.
 
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Brand Name
MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
Type of Device
SAW, 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
james gonzales
7000 w. william cannon drive
austin, TX 78735
MDR Report Key6535633
MDR Text Key74257073
Report Number1643264-2017-00239
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,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberED72200616
Device Lot NumberAAX 5824
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/10/2017
Initial Date FDA Received05/01/2017
Supplement Dates Manufacturer Received04/10/2017
Supplement Dates FDA Received08/29/2017
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
Patient Sequence Number1
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