MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 6 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-607
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The foam plate was incorrectly placed in the packaging and partially welded to the packaging.It was questionable if the inlay was completely sterile.Insert was not used due to having a replacement available.No surgical delay.No adverse affects on the patient.
Additional 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.
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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: a.Did the inner foam got stuck on the inner packaging? it got stuck between the paper lid and the plastic case.B.Was the seal broken/sterile integrity of the package breached? the sterile integrity of the package was breached.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the complaint.The seal adhesive transfer was incorrectly placed on the blister flange.However, there is no impact on the sterility of the unit or integrity of the sterile barrier.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.Device history lot: 1) quantity manufactured: 17.2) date of manufacture: sep/02/2021.3) any anomalies or deviations identified in dhr: no none conformances associated to this lot.4) expiry date: aug/31/2026.5) ifu reference: 090200829.Device history review: 1) quantity manufactured: 17.2) date of manufacture: sep/02/2021.3) any anomalies or deviations identified in dhr: no none conformances associated to this lot.4) expiry date: aug/31/2026.5) ifu reference: 090200829.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the complaint.The seal adhesive transfer was incorrectly placed on the blister flange.Based on the review of the photos, the seal adhesive was confirmed to be missing along one edge of the blister packaging.Although the missing seal adhesive would compromise the sterility of the blister packaging, there is a second sterile barrier (vacuum sealed foil pouch) designed to maintain the sterile integrity of the implant itself.There is no evidence from the photos provided of the inner vacuum sealed foil pouch damaged or compromised in any way.Therefore, due to the integrity of the inner sterile barrier is uncompromised, the reported compromised sterility is not confirmed.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.Device history lot : 1) quantity manufactured: (b)(4), 2) date of manufacture: sep/02/2021, 3) any anomalies or deviations identified in dhr: no none conformances associated to this lot, 4) expiry date: aug/31/2026, 5) ifu reference: 090200829.Device history review : 1) quantity manufactured: (b)(4), 2) date of manufacture: sep/02/2021, 3) any anomalies or deviations identified in dhr: no none conformances associated to this lot, 4) expiry date: aug/31/2026, 5) ifu reference: 090200829.

• Brand Name: ATTUNE CR RP INSRT SZ 6 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14166290
• Report Number: 1818910-2022-07165
• Device Sequence Number: 14935849
• Product Code: NJL
• UDI-Device Identifier: 10603295047889
• UDI-Public: 10603295047889
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 1516-30-607
• Device Catalogue Number: 151630607
• Device Lot Number: 9874864
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 09/30/2022; 03/01/2023
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 09/29/2022; 10/02/2022; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown