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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 LM/RL KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI TIB CUT BLK LM/RL KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 202440100
Device Problems Cut In Material (2454); Material Deformation (2976)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Examination of the returned device confirmed raised material at the edge of the cutting slot. 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 the tibial cutting blocks have sharp edges.
 
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Brand NameSIGMA HP UNI TIB CUT BLK LM/RL
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 Key6804082
MDR Text Key104165382
Report Number1818910-2017-23075
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number202440100
Device Lot NumberA0809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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