MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV LPS INSRT XSM 12MM; KNEE TIBIAL INSERT

Model Number	1517-60-212
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 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.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 lps insert and the sterile paper packaging wouldn't remove the sterile layer to allow the implant to be opened correctly.Tried a different corner to get the paper to release, but all four corners were stuck fast and ended up tearing between the layers of packaging paper.
Event or Problem Description
Additional information received.The affected side of the patient was the left knee.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned.Based on the visual analysis of the provided photographic evidence, it was possible to confirm that tyvek lid of was not possible to be properly retrieved from the adhesive of the sterile package.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: nr-0190177 was launched in depuy synthes quality systems,  upon review of the audit trail, it was found that batch jp9016 was sent for sterilization twice due to damaged and dirty condition of unit cartons.They were dispositioned to have the unit cartons and unit carton labels replaced.The non-standard rework activity did not call for sterilization of the product upon completion, as the sterile barrier was not breached as part of the rework activity.However, upon completion of the rework activity and systematic release of the product, it was inadvertently sent through the sterilization process a second time.
Additional Manufacturer Narrative
H7 and h9: recall information provided.

• Brand Name: ATTUNE REV LPS INSRT XSM 12MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15561779
• Report Number: 1818910-2022-19782
• Device Sequence Number: 5684857
• Product Code: KRO
• UDI-Device Identifier: 10603295490968
• UDI-Public: 10603295490968
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K191779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/07/2022

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 Model Number: 1517-60-212
• Device Catalogue Number: 151760212
• Device Lot Number: JP9016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 01/26/2023; 02/28/2024
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/24/2022; 01/26/2023; 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-02/09/2023-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown