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U.S. Department of Health and Human Services

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

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SYNTHES OBERDORF SMALL BATTERY DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.110
Device Problems Loose or Intermittent Connection (1371); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2017
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 hand pining extremity surgical procedure, it was observed that the small battery drive device was not working properly; would turn on and off, and had a bad connections and a loose gold prong. According to the report, the device was in use one minute before the event occurred. It was further reported that there was a five minute delay in the surgical procedure. It was reported that a spare device was not used/needed. There was patient involvement reported. There were no 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
Additional narrative: the actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition of the device not working properly, would turn on and off, and with bad connections and gold prong was loose was not confirmed. Therefore, the assignable root cause was not determined. However, during evaluation, it was noted that the bearings were corroded, the fillister head screw came loose and the motor was making an unusual noise. It was determined that these failures were due to wear from normal wear (loctite degradation) and improper cleaning (cleaning and maintenance procedures not followed per directions for use). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameSMALL BATTERY DRIVE II
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 Key6414576
MDR Text Key70317773
Report Number8030965-2017-11325
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 03/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.110
Device Lot Number1298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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