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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER DRILL; SAW, POWERED, AND ACCESSORIES
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SMITH & NEPHEW, INC. DYONICS POWER DRILL; SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205785
Device Problem Circuit Failure (1089)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2018
Event Type  malfunction  
Event Description
It was reported that the device shorted.No delay or patient injures were reported.
 
Manufacturer Narrative
Device evaluation: the device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and corrosion was observed on the cable connector pins and sockets.A prong was missing in the cable connector.A functional evaluation revealed the motor would not run.The complaint of shorting was confirmed and the root cause was associated with electrical component failure.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include inadvertent damage to the cable.
 
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Brand Name
DYONICS POWER DRILL
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key7369755
MDR Text Key103658159
Report Number3003604053-2018-00050
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010410702
UDI-Public(01)03596010410702
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 07/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7205785
Device Catalogue Number7205785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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