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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP PAT RES GUIDE; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
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DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP PAT RES GUIDE; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 950501121
Device Problems Difficult to Insert (1316); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2019
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.Device is an instrument and is not implanted/explanted.
 
Event Description
(b)(4).Sigma hp pat res guide - not working.This was discovered to be faulty during a case yesterday.The surgery was not slowed down and the patient was not affected.
 
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Brand Name
SIGMA HP PAT RES GUIDE
Type of Device
KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key8460813
MDR Text Key140629504
Report Number1818910-2019-88847
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295224815
UDI-Public10603295224815
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number950501121
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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