• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.010
Device Problems Break (1069); Sticking (1597); Device Operates Differently Than Expected (2913); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device had no power (did not function), the trigger was sticking, the coupling head was worn, the electric motor was worn and the wire insulation on the electronic control unit was damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from use and servicing over time.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 pre-surgery setup, it was observed that the small battery drive device would not do anything.During in-house engineering evaluation, it was observed that the trigger was sticking, the device did not function, the wire insulation on the electronic control unit was damaged, and the coupling head and electric motor were worn.There were no delays to the planned surgical procedure.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SMALL BATTERY DRIVE
Type of Device
INSTRUMENT, 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
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5842629
MDR Text Key52393221
Report Number8030965-2016-14421
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number532.010
Device Lot Number2779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2016
Initial Date Manufacturer Received 07/25/2016
Initial Date FDA Received08/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-