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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.010VET
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2017
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: (b)(4). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that during a veterinary tibial plateau leveling osteotomy (tplo) surgery, it was observed that the small battery drive device had intermittent operation. There was a sixty minute delay to the surgical procedure. A spare device was available to complete the surgery. There was no human patient involvement as the device was used in a veterinary procedure. 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 report will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was not confirmed. Therefore, an assignable root cause was not determined. However, during evaluation, it was determined that the device did not work at all and was not functional. It was further determined that the coupling head was worn. It was observed that the electric motor was damaged, the device had rough rotation and the magnets came off the main gear. It was further determined that the contacts were corroded on the electronic control unit and the gear parts and seals were worn. It was determined that there was corrosion on the internal components. It was further determined that these issues were consistent with component wear. The assignable root cause was determined to be due to wear from normal use over time. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
 
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Brand NameSMALL BATTERY DRIVE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6435553
MDR Text Key70907616
Report Number8030965-2017-11459
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.010VET
Device Lot Number003962
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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