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U.S. Department of Health and Human Services

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

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SYNTHES OBERDORF RADIOLUCENT-DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.300
Device Problem Vibration (1674)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reporter number was not provided. 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 event 3 of 4 of the same event. It was reported from (b)(6) that during a diaphyseal spiral surgical procedure for a humeral diaphysis fracture, it was observed that while using the radiolucent drive device the drill bit devices started to wobble. According to the reporter, the drill bit devices then stopped moving while in use with the device. The reporter stated that the surgeon attempted to drill while holding the base tight as the surgeon believed there was a connection issue with the handpiece device. However, the surgeon noted that the junction of the drill bit device and quick coupling device did not work properly. The reporter stated that the surgeon then attempted to fix the drive tip with tape so that the drill bit device would not fall without success. The reporter stated that eventually the drill but device tip was hit with a hammer. Therefore, the surgeon opened the other side with his hand and inserted screw devices to continue the surgical procedure. The reporter further indicated that a compact air drive device was in use during the procedure. According to the reporter, the cutter device did not break during the surgical procedure. It was unknown if a spare device was available for use. There was patient involvement. There was a thirty minute delay to the surgical procedure which caused the patient to lose blood. The amount of blood loss was not available from the reporter. The reporter was not able to specify if/what medical intervention was performed or if there was prolonged hospitalization as a result of the event. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
(b)(4). During subsequent follow-up with the customer, it was reported that there was an additional cutter device involved in this event. Therefore, this is report 3 of 5 of the same event. (b)(4). (b)(6). The date of manufacture was documented as unknown in the initial report and has been updated as oct 26, 2000. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
The date returned to manufacturer was documented as jan 27, 2017 on the initial report. It has been updated as feb 1, 2017. Device evaluation: the actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the device passed all operational specifications. There was no failure identified. Therefore, the reported condition was not 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 NameRADIOLUCENT-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 Key6221345
MDR Text Key63824430
Report Number8030965-2017-10023
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511.300
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2000
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: 01/04/2017 Patient Sequence Number: 1
Treatment
COMPACT AIR DRIVE; CUTTER DEVICE; QUICK COUPLING DEVICE
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