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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI TIB CUT BLK RM/LL KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI TIB CUT BLK RM/LL KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 202440200
Device Problems Difficult to Remove (1528); Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 07/17/2017
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: the device associated with this report was not returned for evaluation. Depuy considers the investigation closed. 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.
 
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 during case, screw lodged into the uni rm/ll cutting block. It is stated that the screw is still in block and can't be remove.
 
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Brand NameSIGMA HP UNI TIB CUT BLK RM/LL
Type of DeviceKNEE 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 Key6794521
MDR Text Key104060373
Report Number1818910-2017-22758
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number202440200
Device Lot NumberA1009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2009
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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