MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 8 CEM; KNEE TIBIAL TRAY

Catalog Number 150680008

Device Problems Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(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 when the nurse opened the packaging of the tibia baseplate, the outer layer of the packaging did not rip completely off and there were remnants on the rim of the baseplate.The surgeon feared that the packaging was contaminated so he opted to open a new implant.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthesof 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary : the packaging components associated with the reported event were not returned for evaluation.Review of manufacturing records did not reveal any manufacturing deviations or anomalies.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP TIB BASE SZ 8 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9135848
• MDR Text Key: 186585045
• Report Number: 1818910-2019-106825
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295492207
• UDI-Public: 10603295492207
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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 Catalogue Number: 150680008
• Device Lot Number: 9141576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1