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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 11CM ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

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DEPUY SYNTHES POWER TOOLS 11CM ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT Back to Search Results
Catalog Number QD11
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 06/10/2015
Event Type  malfunction  
Manufacturer Narrative
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 normal use and servicing.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 from (b)(6) that during service and repair, it was observed that the 11cm angle attachment device had defective drive shaft and bearing and damaged sleeve.This event was not related to surgery.There was no patient involvement.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
11CM ANGLE ATTACHMENT
Type of Device
MOTOR, DRILL, ELECTRIC - ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens 33410
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens 33410
Manufacturer Contact
rodney crain
4500 riverside drive
palm beach gardens, FL 33410
5616271080
MDR Report Key5569864
MDR Text Key42981630
Report Number1045834-2016-11077
Device Sequence Number1
Product Code HBC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
PK011444
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 06/10/2015
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 NumberQD11
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/10/2015
Initial Date FDA Received04/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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