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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL S.A. UNIVERSAL OSCILLATING SAW ATTACHMENT
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ZIMMER SURGICAL S.A. UNIVERSAL OSCILLATING SAW ATTACHMENT Back to Search Results
Catalog Number 89-8509-450-60
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2015
Event Type  malfunction  
Event Description
It has been reported that prior to surgery, two pins of the oscillating saw attachment were broken.No pt harm or injury has been reported.No surgery delay has been reported.
 
Manufacturer Narrative
The device was not returned to the manufacturer at the time of this present report, the investigation is not completed.A medwatch f/u will be submitted when the investigation is completed.
 
Manufacturer Narrative
The universal oscillating saw attachment, serial number (b)(4) was not returned for complaint investigation.The device could not be visually inspected in an effort to confirm the defect.A follow up medwatch will be submitted if the product is returned.
 
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Brand Name
UNIVERSAL OSCILLATING SAW ATTACHMENT
Type of Device
UNIVERSAL OSCILLATING SAW ATTACHMENT
Manufacturer (Section D)
ZIMMER SURGICAL S.A.
chemin pre fleuri 3
plan les ouates, geneva CH-12 28
SZ  CH-1228
Manufacturer Contact
cecile guiot
chemin pre fleuri 3
plan les ouates, geneva CH-12-28
SZ   CH-1228
27062106
MDR Report Key4644660
MDR Text Key5680650
Report Number8031000-2015-00039
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeIR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number89-8509-450-60
Device Lot NumberAF57172
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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