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U.S. Department of Health and Human Services

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

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SYNTHES OBERDORF 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 Energy Output Problem (1431); Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 03/14/2014
Event Type  malfunction  
Manufacturer Narrative
The 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. The assignable root cause was determined to be due to improper repair. If additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported that during service and repair, it was observed that the electric pen handpiece device was found with the wiring and soldering open, bad contact and the handpiece was not oscillating at the correct speed. There was no 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).
 
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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)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer (Section G)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5510998
MDR Text Key40862191
Report Number8030965-2016-11714
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial,Followup
Report Date 03/14/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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