MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV FB PS TB TRL SZ3; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500973
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary; examination of the returned 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.
Event or Problem Description
It was reported that the articulating surface cracked; all pieces retrieved.No surgical delay.

• Brand Name: ATTUNE CONV FB PS TB TRL SZ3
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7767384
• Report Number: 1818910-2018-66218
• Device Sequence Number: 16735801
• Product Code: JWH
• UDI-Device Identifier: 10603295135500
• UDI-Public: 10603295135500
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: 254500973
• Device Lot Number: BFA0PK3
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR