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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 532.010_DL
Device Problems Mechanical Problem (1384); Sticking (1597); Vibration (1674); Failure to Advance (2524); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device coupling head malfunctioned and would not accept the gauge, the upper trigger was sticking, the electric motor was rotating roughly, the device had strong vibrations and the trigger components and coupling head were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from normal 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, it was observed that the small battery drive device would not load the attachment device.During service and repair, it was observed that the device coupling head malfunctioned and would not accept the gauge, the upper trigger was sticking, the electric motor was rotating roughly, the device had strong vibrations and the trigger components and coupling head 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.
 
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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 Key5821742
MDR Text Key51237454
Report Number8030965-2016-14335
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 company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/27/2016
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_DL
Device Lot Number4818
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/18/2016
Initial Date FDA Received07/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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