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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.010
Device Problems Overheating of Device (1437); Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2018
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. The actual device was returned for evaluation. The small battery drive device was evaluated and the reported condition that the device stopped turning, no noise, got unusually warm was confirmed. An assessment was performed and it was observed that the device failed the off/oscillation/on switch mode function check, because the device did not oscillate, failed the safety assessment (check the off/oscillation/on switch mode function) because the device does not run and when the trigger is pressed there is no function and no motion, and the device failed the ohms test check. During repair it was observed that the ball bearings were corroded, the motor seized and would not rotate when power was applied, the shaft of the motor was corroded, and the device showed signs of immersion. The assignable root cause was determined to be due to improper cleaning, which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported that during an unspecified surgical procedure of the foot it was observed that the small battery drive device had stopped turning, had no movement or sound, and was getting unusually warm. It was reported that there was a five minute delay in the procedure due to the event, and an unspecified spare device was available for use. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameSMALL BATTERY DRIVE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7334835
MDR Text Key102274643
Report Number8030965-2018-51994
Device Sequence Number1
Product Code HWE
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
Report Date 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/30/2005
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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