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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF SMALL BATTERY DRIVE II VET SALE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES OBERDORF SMALL BATTERY DRIVE II VET SALE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.110VET
Device Problems Overheating of Device (1437); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2017
Event Type  malfunction  
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. It was determined that the unit was found not to be working. The unit was being used with oscillating saw attachment device. The two units were tested together and the oscillating saw attachment device was found to be working as expected. A visual and functional assessment was performed which found that the unit was not working. During repair, it was observed that the motor was damaged and did not rotate (no ampere). It was determined that the bearings were corroded and the coupling head was worn. It was further determined that the issues were consistent with normal 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.
 
Manufacturer Narrative
Udi: (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
This is report 1 of 2 for the same event: it was reported that during an unspecified veterinary surgical procedure, it was discovered that the small battery drive device was working inconsistently. It was further reported that it was difficult to insert and attach the oscillating saw attachment device to the handpiece device. According to the reporter, when the device was cooled, it sometimes worked. However, the device did not work when it became hot. It was further reported that the device seemed to have a connection issue. The device worked sometimes and then it stopped working. The reporter stated that the issue was dependent on the way the device was being held and if it was hot or not. There was minimal delay to the surgical procedure. However, the duration of the delay was not specified. It was not reported if spare devices were available for use. There was no human patient involvement as the devices were used in a veterinary procedure. It was not reported if there were any 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.
 
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Brand NameSMALL BATTERY DRIVE II VET SALE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer (Section G)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6823657
MDR Text Key197388057
Report Number8030965-2017-14546
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,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.110VET
Device Lot Number1881
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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