MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION MODULAR STOP; ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES

Catalog Number	254600500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.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
It was reported that 7 attune revision modular stop pieces do not work with the tibial stem reamer, they do not slide down to lock in.There was a manufacturing problem and it was never in a surgery.

• Brand Name: ATTUNE REVISION MODULAR STOP
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7800635
• Report Number: 1818910-2018-67198
• Device Sequence Number: 16629247
• Product Code: LXH
• UDI-Device Identifier: 10603295478607
• UDI-Public: 10603295478607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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: 254600500
• Device Lot Number: SO2028208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1