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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS EPD 60000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS EPD 60000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.010
Device Problems Moisture Damage (1405); Device Inoperable (1663); Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). 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 confirmed. The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.

 
Event Description

It was reported by (b)(6) that the electric pen drive device was not working. During the pre-repair diagnostics assessment, it was determined that the device ran by itself. It was determined that the electronic control unit (ecu) was faulty and water stains were found on the motor surface. It was further determined that the device failed for check function and direction of rotation, check function with test hand switch, check function with foot pedal and for check with test hand switch. 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 report will be submitted accordingly.

 
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Brand NameEPD 60000 RPM
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
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6157534
MDR Text Key62376916
Report Number8030965-2016-15867
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/03/2016
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 HEALTH PROFESSIONAL
Device Catalogue Number05.001.010
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/24/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/11/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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