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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS CABLE 3M TO CONSOLE FOR ELECTRIC PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS CABLE 3M TO CONSOLE FOR ELECTRIC PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.025
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2016
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 additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
This is report 1 of 2 for the same event: it was reported from (b)(6) that during a partial mandibulectomy on a patient with a lower gingival carcinoma, it was discovered that the electric pen drive device and the cable device were suspected to have a loose connection. According to the report, the surgeon used a cutting burr device with the electric pen drive device to remove the lesion. However, during reconstruction surgery of the mandible, it was observed that the electric pen drive device did not work well and just stopped when the surgeon made a hole with a j-latch attachment. It was further reported that the surgeon thought that the device would work and stop depending on the attachment with the handpiece. It was not reported whether there were any delays and the surgery was completed with another device. There was 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.
 
Manufacturer Narrative
(b)(4). The lot number was documented as unknown in the initial report. It has been updated as 8492258. The manufacturer location was documented as unknown in the initial report. The location has been updated to (b)(4). Contact office name/address has been updated accordingly to reflect the correct manufacturing facility. The device manufacture date was documented as unknown in the initial report. It has been updated to december 18, 2013. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. During subsequent follow-up, it was clarified that the pen drive device was working intermittently. It was also reported that it was suspected that the pen drive device cable and switch were malfunctioning. It was also reported that there was no allegation of malfunction against the attachments but when the customer used the j-latch for the pen drive device for drilling the pen drive device was stopping. It was further reported that the customer did not complain about the j-latch because the customer felt the function of the pen drive was irregular.
 
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Brand NameCABLE 3M TO CONSOLE FOR ELECTRIC PEN DRIVE
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 Key6080565
MDR Text Key59560766
Report Number2520274-2016-15235
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 10/19/2016
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
Device Catalogue Number05.001.025
Device Lot Number8492258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/18/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/04/2016 Patient Sequence Number: 1
Treatment
ATTACHMENT DEVICE; ELECTRIC PEN DRIVE DEVICE
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