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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS CABLE F/ELECTRIC PEN DRIVE+SMALL ELECTRI INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS CABLE F/ELECTRIC PEN DRIVE+SMALL ELECTRI INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.021
Device Problem Failure to Shut Off (2939)
Patient Problem No Patient Involvement (2645)
Event Date 10/22/2016
Event Type  Malfunction  
Manufacturer Narrative

Udi: (b)(4). Reporter's phone number: (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

This is report 3 of 3 of the same event. It was reported from (b)(6) that the after plugging the electric pen drive device to the electric socket the device ran continuously. The electric pen drive device was in use with the cable device and hand switch device. The event did not occur during a surgical procedure. There was no patient involvement reported. 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.

 
Manufacturer Narrative

The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the device passed all manufacturing specifications. Therefore, the reported condition was not duplicated and confirmed. An assignable root cause was not determined. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameCABLE F/ELECTRIC PEN DRIVE+SMALL ELECTRI
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 Key6080165
MDR Text Key59513004
Report Number8030965-2016-15446
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 10/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number05.001.021
Device LOT Number1702012
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/25/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/04/2016 Patient Sequence Number: 1
Treatment
ELECTRONIC PEN DRIVE; HANDSWITCH DEVICE
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