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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); Partial Blockage (1065); Break (1069); Retraction Problem (1536); Device Operates Differently Than Expected (2913); Naturally Worn (2988); Power Problem (3010); Torn Material (3024); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: (b)(4). The manufacturing location was unknown. Device manufacture date is currently unavailable. The 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 device wear from normal use and servicing. If additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported by (b)(6) that the compact air drive device had an undetermined malfunction. During service and evaluation, it was observed that the compact air drive gear was broken, torn off and noted that the motor was blocked, gear damaged, bearings and seals worn out. It was further observed that the device failed pre-test for reverse locking mechanism, air leak, triggers for forward and reverse mode, untrue running, excessive noise, power with test bench and starting behavior. 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 NameCAD II
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
ni
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
ni
ni
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6158070
MDR Text Key62383883
Report Number8030965-2016-15883
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2016
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 Manufacturer11/18/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
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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