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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS CAD II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.701
Device Problems Break (1069); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Naturally Worn (2988)
Patient Problem No Patient Involvement (2645)
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 duplicated and confirmed. The assignable root cause was determined to be due to normal wear from use and servicing over time. If additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported from netherlands that during service and evaluation, it was discovered that the compact air drive device motor had seized, was jammed, heavy moving, the motor shaft and push button were worn, the rotary knob did not function properly and the casing was damaged. It was also observed that the device failed the following pre-tests: general condition, check the attachment coupling, check attachment coupling with attachments, check function of soft mode switch (safety system), check for excessive noise and check starting behavior. The event was not related to surgery. There was no patient involvement reported. There were no injuries, delays, or medical intervention associated with this event. 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 NameCAD 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 Key6069318
MDR Text Key59220097
Report Number8030965-2016-15414
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 10/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511.701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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