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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS ELECTRIC PEN DRIVE 60,000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS ELECTRIC PEN DRIVE 60,000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.010
Device Problems Loose or Intermittent Connection (1371); Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition of the intermittent function could not be confirmed. Therefore, an assignable root cause was not determined. However, the loose component reported was confirmed. It was determined that the device was found to have a loose component; therefore, the device could not be completely tested. It was determined that the release sleeve had come off. It was further determined that the device failed the cable coupling test and the switch sleeve would not rotate with the gauge inserted. It was further determined that the electric motor/electronic control unit assembly had aged (non-failure). The assignable root cause of the loose component was determined to be due to wear from normal use over time. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported from (b)(6) that during a prodisc nova surgical procedure, it was observed that the electric pen drive device was functioning intermittently. According to the reporter, when the surgeon went to create the keel cut with the device, they noticed the device was having difficulty. It was reported that the surgeon stopped using the device and examined it. They noticed that a section of the distal end of the device was loose. It was not reported if there were any delays in the surgical procedure. A spare device was available to complete the surgery. There was 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.
 
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Brand NameELECTRIC PEN DRIVE 60,000 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6639917
MDR Text Key77532425
Report Number8030965-2017-12988
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K043310
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 05/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.010
Device Lot Number2710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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