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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  HP CLASSIC ROT GDE 3DEG; KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. 1818910  HP CLASSIC ROT GDE 3DEG; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 950501274
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 10/12/2017
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the hp classic rot gde 3deg broke during a cadaver lab training.
 
Manufacturer Narrative
Additional narrative: depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
HP CLASSIC ROT GDE 3DEG
Type of Device
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key7017712
MDR Text Key91960472
Report Number1818910-2017-28728
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295225775
UDI-Public10603295225775
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/12/2017
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
Device Operator Health Professional
Device Catalogue Number950501274
Device Lot NumberPG0908
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2017
Initial Date FDA Received11/10/2017
Supplement Dates Manufacturer Received11/14/2017
Supplement Dates FDA Received11/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2008
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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