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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

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SYNTHES OBERDORF OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL Back to Search Results
Catalog Number 511.801
Device Problems Break (1069); Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 03/24/2014
Event Type  malfunction  
Manufacturer Narrative
This 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 wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported from italy that during service and repair, it was observed that the oscillating saw attachment device was broken and torn off.This event was not related to surgery.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.
 
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Brand Name
OSCILLATING SAW ATTACHMENT II
Type of Device
BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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 Key5470125
MDR Text Key39699711
Report Number8030965-2016-11046
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
PEXEMPT
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
Report Date 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number511.801
Device Lot Number8035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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