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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.110
Device Problems Device Stops Intermittently (1599); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2018
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. The actual device was returned for evaluation. Reliability engineering evaluated the device and determined that the reported condition that the bottom trigger was sticking and the motor would run by itself was confirmed. An assessment was performed and it was observed that the bottom trigger was binding and sticking when it was pressed, the device showed signs of an immersion, there was excessive corrosion in the internal sub-assemblies¿ components, unknown debris on the ball bearings, the triggers were corroded, and the motor was corroded. It was further determined that the device failed pretest for check off/oscillation/on switch mode function, check continuously oscillating, and the trigger and electronic control unit (ecu) function check. 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, it was observed that the bottom trigger on the small battery drive device was sticking and making the motor run without being pressed. It was reported that the trigger was put out to get the motor to stop running. It was not reported if there was a delay in the procedure due to the event. It was not reported if there was a spare device 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 II
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 Key7393425
MDR Text Key104560955
Report Number8030965-2018-52726
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 03/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/15/2015
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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