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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURANCE VERSION CONTROL GDE; HIP INSTRUMENTS : ALIGNMENT DEVICES
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DEPUY ORTHOPAEDICS INC US ENDURANCE VERSION CONTROL GDE; HIP INSTRUMENTS : ALIGNMENT DEVICES Back to Search Results
Model Number 2521-00-503
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/02/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).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
Endurance inserted was visibly cracked on the white silicone portion.Was found after the case by mdrd.
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy-synthes 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.
 
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Brand Name
ENDURANCE VERSION CONTROL GDE
Common Device Name
HIP INSTRUMENTS : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10148295
Report Number1818910-2020-13705
Device Sequence Number2050723
Product Code HWT
UDI-Device Identifier10603295127802
UDI-Public10603295127802
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/02/2020
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 Model Number2521-00-503
Device Catalogue Number252100503
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/02/2020
Supplement Date Received by Manufacturer07/20/2020
Initial Report FDA Received Date06/12/2020
Supplement Report FDA Received Date07/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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