MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV FB PS TB TRL SZ9; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500979
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
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
Total knee replacement - dr.(b)(6), (b)(6) on (b)(6) 2017.While performing a total knee replacement, it was noticed that there was damage to an attune articulating surface as well as 2 attune shims.This damage includes a silver o ring broken from a shim and stuck to the articulating surface as evidenced by photos attached to this email.The additional shim has a small crack in it.These were noticed before being used on the patient.No delay or adverse result was reported.(b)(6).No surgical delay.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the reported device was not returned for evaluation, however review of the provided photographs confirms the reported event.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 CONV FB PS TB TRL SZ9
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7178108
• Report Number: 1818910-2018-50769
• Device Sequence Number: 1274477
• Product Code: JWH
• UDI-Device Identifier: 10603295135562
• UDI-Public: 10603295135562
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 254500979
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1