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

Catalog Number	250440002
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Brand Name: ATTUNE REV BOX CUT PLATFORM
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8155517
• Report Number: 1818910-2018-77889
• Device Sequence Number: 1732115
• Product Code: HTZ
• UDI-Device Identifier: 10603295442899
• UDI-Public: 10603295442899
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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 Number: 250440002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1