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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF LID FOR RECON SAGITTAL SAW FOR TRAUMA RECON SYSTEM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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SYNTHES OBERDORF LID FOR RECON SAGITTAL SAW FOR TRAUMA RECON SYSTEM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number 05.001.241
Device Problems Difficult to Open or Close (2921); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(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.
 
Event Description
This is report 1 of 2 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that it was not possible to close the lid of the sagittal saw handpiece device because either the lid of the sagittal saw handpiece device was deformed, or the sagittal saw device was deformed.It was reported that there was a ten minute delay in the procedure and an unspecified spare device was available to complete the procedure successfully.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.It was reported that the patient is in good condition.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which found that the lock-plate was deformed.The lock-device can be switch from "lock" to "unlock position" without pressing the push-button.It was noted that the turning knob was loose and the lid was not tight anymore.The assignable root cause was determined to be due to construction/design being false, defective.This issue has been captured in a capa.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
LID FOR RECON SAGITTAL SAW FOR TRAUMA RECON SYSTEM
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5978092
MDR Text Key55998061
Report Number8030965-2016-14968
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05.001.241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
SAGITTAL SAW HANDPIECE DEVICE
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