MAUDE Adverse Event Report: DEPUY IRELAND 961610 ATUN REV RP INSRT TRL SZ7 6MM; TIBIAL TRIALS

Catalog Number	251710706
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 attune knee revision rp insert trial sz 7 6mm did not fit in trial femur.Manufacturing error.A replacement trial was ordered and put our set, and works well.Might be a problem with a specific lot.2517-10-706 lot az887033.Surgical delay for 5 minutes.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary evaluation and measurement of the returned device was unable to confirm the reported event.The returned device met print specification.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: ATUN REV RP INSRT TRL SZ7 6MM
• Common Device Name: TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• MDR Report Key: 7562251
• Report Number: 1818910-2018-61165
• Device Sequence Number: 10795840
• Product Code: NJL
• UDI-Device Identifier: 10603295477051
• UDI-Public: 10603295477051
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: 251710706
• Device Lot Number: AZ887033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1