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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733734
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The ratcheting handle was returned to the manufacturer for analysis.Analysis found that the end cap had broken off and is missing.Otherwise, the instrument retention and ratchet mechanisms are intact and functional.Analysis found that the reported event was related to a mechanical issue.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the ratcheting handle cap came off the handle during sterile processing.There was no patient present at the time of the event.
 
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Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC
louisville,co 80027
MDR Report Key8649344
Report Number3004785967-2019-00948
Device Sequence Number3020644
Product Code OLO
UDI-Device Identifier00643169089600
UDI-Public00643169089600
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K124004
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number9733734
Device Catalogue Number9733734
Device Lot Number103130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2018
Initial Report FDA Received Date05/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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