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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 Problems Connection Problem (2900); Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2016
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: 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
It was reported from (b)(6) that during a tibial diaphysis fracture surgical procedure, it was observed that the radiolucent drive device stopped rotating (drilling) when the surgeon tried to perform a distal locking on the etn (expert tibial nail). It was reported that the surgeon then found a gap at the attachment part (protruded portion) of the device where drill bit device was installed. There was a gap between the body of the device and the protruded part. The gap was filled gradually when the rotating started. The reporter stated that the device started working smoothly after the surgeon used forceps to forcefully help with the rotation. The reporter stated that there was an unknown trauma and recon system device also involved in this event. According to the reporter, there was no allegation of malfunction against the trauma and recon system device (trs). There was a fifteen minute delay to the surgical procedure. It was not reported if a spare device was available for use. 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.
 
Manufacturer Narrative
(b)(6). 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
Additional narrative:the actual device was returned for evaluation. Reliability engineering evaluated the device. A functional assessment was performed and no failures were identified. The reported condition was not duplicated or confirmed. Therefore, 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
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5547317
MDR Text Key42515264
Report Number8030965-2016-12181
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK971544
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
Report Date 03/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2016
Is this an Adverse Event Report? No
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 Manufacturer04/13/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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