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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI TIB CUT BLK RM/LL; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI TIB CUT BLK RM/LL; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 202440200
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 10/21/2016
Event Type  malfunction  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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
During a uni knee arthroplasty, a threaded pin with stop broke into the tibial cutting guide.
 
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Brand Name
SIGMA HP UNI TIB CUT BLK RM/LL
Type of Device
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6088741
MDR Text Key59455092
Report Number1818910-2016-31133
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 10/21/2016
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 Number202440200
Device Lot NumberS02016188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/21/2016
Initial Date FDA Received11/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2014
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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