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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS FEM FLATNESS GAGE KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS

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DEPUY ORTHOPAEDICS INC US LCS FEM FLATNESS GAGE KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS Back to Search Results
Model Number 2267-44-000
Device Problems Break (1069); Crack (1135); Material Discolored (1170); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Broken attune shims and lcs ruler reported by cssd staff.
 
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Brand NameLCS FEM FLATNESS GAGE
Type of DeviceKNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10106804
MDR Text Key193410111
Report Number1818910-2020-12972
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2267-44-000
Device Catalogue Number226744000
Device Lot NumberBF0603
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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