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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 Air Leak (1008); Retraction Problem (1536); Difficult or Delayed Activation (2577); Connection Problem (2900); Device Markings/Labelling Problem (2911); Failure to Shut Off (2939); Naturally Worn (2988); Power Problem (3010); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2016
Event Type  Malfunction  
Manufacturer Narrative

Additional narrative: (b)(4). The manufacturing location was unknown. Device manufacture date is unknown. (b)(6). 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 improper maintenance which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch report will be sent accordingly.

 
Event Description

It was reported from (b)(6) that the compact air drive device did not stop. During an in-house engineering evaluation, it was observed that the device was had general wear out, bad general condition and worn body. It was further noted that the device failed pre-test for general condition, attachment coupling, attachment coupling with attachments, air hose coupling, triggers for forward and reverse mode, untrue running, air leak, function of soft mode switch (safety system), marking and labeling, reverse locking mechanism, power with test bench: min. 110 to 160 w, excessive noise and starting behavior. It was not reported if the device was used in surgery, or if there was patient involvement reported. It was not reported if there were any delays in a scheduled surgical procedure or if a spare device was available for use. It was not reported if there were any 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 NameCAD II
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
ni
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6113121
MDR Text Key60856160
Report Number2520274-2016-15439
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberEXEMPT
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 11/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/18/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number511.701
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/08/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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