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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.110_LL
Device Problems Break (1069); Corroded (1131); Fluid Leak (1250); Loose or Intermittent Connection (1371); Sticking (1597); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. The assignable root cause was determined to be due to component damage caused by improper cleaning methods and components worn from normal use over time. If additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported that during pre-surgery, it was observed that the small battery drive was working intermittently. During in-house engineering evaluation, it was observed that the triggers were sticking, an unknown liquid was found on the electronic control unit, an unknown residue and corrosion on electric motor contact, loose contact pin on electronic control unit and broken safety disc. There were no delays in the surgical procedure as a spare device was available for use. There was no 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 report 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 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
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6061599
MDR Text Key59013042
Report Number8030965-2016-15367
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
Report Date 09/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.110_LL
Device Lot Number1512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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