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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REV BOX CUT PLATFORM RESECTION BLOCKS/DEVICES

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DEPUY IRELAND 9616671 ATTUNE REV BOX CUT PLATFORM RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 250440002
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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
(b)(6). (b)(4). The box trial platform has play on the ctt and this could angle your box cut off. An unspecified number of trials checked at the lab, and the same play was observed.
 
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. 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.
 
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Brand NameATTUNE REV BOX CUT PLATFORM
Type of DeviceRESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6107428552
MDR Report Key8155517
MDR Text Key130067893
Report Number1818910-2018-77889
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number250440002
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
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 Initial

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