MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL VICE; IMPLANT STAND

Model Number	2546-00-426
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
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
Revision knee: complex primary case using attune revision procedure.Hospital borrowed tray zzinauk0868 from consigned set.The offset adaptor would not stay in vice and seemed that the tightening mechanism was cross-threaded.No ae reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.

• Brand Name: ATTUNE REVISION TIBIAL VICE
• Common Device Name: IMPLANT STAND
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10165015
• Report Number: 1818910-2020-14036
• Device Sequence Number: 14214357
• Product Code: LXH
• UDI-Device Identifier: 10603295440208
• UDI-Public: 10603295440208
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2020

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 Number: 2546-00-426
• Device Catalogue Number: 254600426
• Device Lot Number: GM5182301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/08/2020; 07/22/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 06/19/2020; 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1