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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED

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DEPUY SYNTHES PRODUCTS LLC COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED Back to Search Results
Catalog Number 511.701
Device Problem Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Reporter¿s phone number was not provided.Device manufacture date is unknown.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the compact air drive device motor was seized, jammed and heavy moving.It was further determined that the device failed pretest for starting behavior, power with the test bench, excessive noise, untrue running, triggers for forward and reverse mode, air leak, cannulation, general condition and status of development.This event did not occur during 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 will be submitted accordingly.
 
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Brand Name
COMPACT AIR DRIVE II
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf
SZ 
Manufacturer (Section G)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf
SZ  
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7148671
MDR Text Key95859986
Report Number8030965-2017-50969
Device Sequence Number1
Product Code HWE
UDI-Device Identifier7611819085268
UDI-Public(01)7611819085268
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/05/2017
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Initial Date Manufacturer Received 12/05/2017
Initial Date FDA Received12/27/2017
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 Unknown
Patient Sequence Number1
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