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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 8; HIP INSTRUMENTS : BROACHES
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DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 8; HIP INSTRUMENTS : BROACHES Back to Search Results
Catalog Number L20408
Medical Device Problem Code Fitting Problem (2183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/28/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned instrument could not confirm the complaint.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.
 
Event or Problem Description
The broaches are out of tolerance, not fitting on the neck trial.
 
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Brand Name
BROACH CORAIL AMT 8
Common Device Name
HIP INSTRUMENTS : BROACHES
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key8266440
Report Number1818910-2019-81642
Device Sequence Number16674116
Product Code HTQ
UDI-Device Identifier10603295258100
UDI-Public10603295258100
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/28/2018
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
Operator of Device Health Professional
Device Catalogue NumberL20408
Device Lot NumberSO2013158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/28/2018
Initial Report FDA Received Date01/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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