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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 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). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. 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 the electric pen drive device stopped working, then started to work but would not switch off. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available. It was not reported if there were any 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.

 
Manufacturer Narrative

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. It was determined that the control unit was not functioning and was defective. It was further determined that the device was unable to operate, the electronic control unit (ecu) was faulty, and the motor had stains on the surface. It was further determined that the device failed for check function and direction of rotation, check function with test hand switch and for check function with foot pedal. 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.

 
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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 Key6103597
MDR Text Key60433100
Report Number8030965-2016-15588
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/15/2016
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 Manufacturer11/22/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/25/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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