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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS DURA GUARD M F/EPD+APD NO. 05.001.059; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS DURA GUARD M F/EPD+APD NO. 05.001.059; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.052
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device manufacture date: the device manufacture date is unavailable.(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and the reported condition was confirmed.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the lid of the dura guard of the craniotome device had broken and seized.It was noted that the number was not visible, and the device was physically damaged.It was noted in the service order that the device was not working.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 the event was not reported.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
DURA GUARD M F/EPD+APD NO. 05.001.059
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
n/i
n/i
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
n/i
n/i
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7029477
MDR Text Key92760522
Report Number8030965-2017-16203
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K043310
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 10/17/2017
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 Number05.001.052
Device Lot NumberNV111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/02/2017
Initial Date FDA Received11/14/2017
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 N
Patient Sequence Number1
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