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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 Partial Blockage (1065)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2013
Event Type  malfunction  
Event Description
It was reported that during an inspection of the universal oscillating saw attachment the hospital noticed that the saw was blocked into oscillating saw.There was no patient harm or delay reported.
 
Manufacturer Narrative
The device was returned to the manufacturer for repair and evaluation.The service record indicates that the device was manufactured on 11/28/2012.Evaluation of the device observed that nut ramp was unscrewed, and a pin was broken.The cause of the reported issue is undetermined.The device was serviced and returned to the customer.
 
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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-1 228
SZ  CH-1228
Manufacturer Contact
kathleen smith
chemin pre fleuri 3
plan les ouates
geneva CH-12-28
SZ   CH-1228
3303438801
MDR Report Key3807327
MDR Text Key4475975
Report Number8031000-2014-00166
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number89-8509-450-60
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/24/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2012
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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