MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-610

Device Problem Difficult to Insert (1316)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/31/2020

Event Type  malfunction  

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 Description

It was reported that the poly would not seat down in front of tray.Tried a different poly and it worked fine.Surgeon felt poly was not manufactured properly.A surgical delay of 10 mins.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device could not confirm the reported event.No evidence was found indicating product error was a contributing factor and the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

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.Patient code: removed not applicable code and replaced with no code available (3191) to capture prolonged surgery.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 6 10MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10402789
• MDR Text Key: 202755772
• Report Number: 1818910-2020-18081
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050100
• UDI-Public: 10603295050100
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2020

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
• Device Operator: Health Professional
• Device Model Number: 1516-40-610
• Device Catalogue Number: 151640610
• Device Lot Number: J5185T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 09/01/2020
• Supplement Dates FDA Received: 08/28/2020; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR