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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF ELECTRIC PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES OBERDORF ELECTRIC PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.010_LL
Device Problems Overheating of Device (1437); Device Stops Intermittently (1599); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2017
Event Type  malfunction  
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the device was not working and there were signs of an unknown substance on top of the motor. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to improper cleaning methods. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4). The actual device has been returned and is currently pending evaluation. Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported that during an unspecified surgical procedure, it was observed that the electric pen drive device was working intermittently. According to the report, the device was working as expected at the beginning of the case. The reporter stated that the device then started working intermittently and heating up. The reporter stated that after a few more minutes, the device stopped working all together. There was an approximate five minute delay to the surgical procedure while a spare device was retrieved. It was reported that the spare device was used to successfully complete the surgery. 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 will be submitted accordingly.
 
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Brand NameELECTRIC PEN DRIVE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer (Section G)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6736786
MDR Text Key194940464
Report Number8030965-2017-13774
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 06/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.010_LL
Device Lot Number101272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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