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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II (CAD II); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II (CAD II); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.701
Device Problems Loose or Intermittent Connection (1371); Sticking (1597); Blocked Connection (2888); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Material Twisted/Bent (2981); Power Problem (3010)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported by (b)(6) that during service and evaluation, it was discovered that the reverse locking mechanism was blocked on the compact air drive device.It was further determined that the top trigger was locked inside the case; the push button was damaged and the reverse lock was jammed.It was further observed when the device was disassembled that the press pin was rusted and twisted.It was observed that the lock pin and upper trigger was blocked in the handpiece.It was further determined that the motor power was insufficient and the motor was found to be very dry.It was further determined during the pre-repair diagnostics that the device failed for check status of development, general condition, check reverse locking mechanism, check triggers for forward/reverse mode and for check the power with test bench: min.110 to 160w.It was noted on the service order that the button was stuck and the contact surface was loose.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.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
COMPACT AIR DRIVE II (CAD II)
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 Key5836348
MDR Text Key52184138
Report Number8030965-2016-14392
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 07/25/2016
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 Number511.701
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/25/2016
Initial Date FDA Received08/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2008
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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