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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS MINI AIR DRILL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS MINI AIR DRILL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 512.100
Device Problem Failure to Shut Off (2939)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This 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 duplicated and confirmed. The assignable root cause was determined to be due to wear from normal use and servicing over time. If additional information should become available, a supplemental medwatch report will be sent accordingly.

 
Event Description

It was reported in the service order from (b)(6) that the mini air drill device ran continuously. During service and evaluation, it was observed that the device motor was blocked, had seized and ran rough. It was further determined that the device failed the following pre-test: check the saw head. 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 NameMINI AIR DRILL
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6238029
MDR Text Key64381797
Report Number8030965-2017-10190
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberEXEMPT
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 12/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number512.100
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/22/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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