MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 3 CEM; KNEE TIBIAL TRAY

Model Number	1506-80-003
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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
The customer complained that a hair was inside the sterile packaging.One part inside and the other part outside.
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.Corrected: h6 (medical device problem code) device contaminated during manufacture or shipping (a1802) is being utilized to capture packaging - foreign matter - inside sterile packaging (foreign material inside sterile packaging) & packaging - foreign matter - outside sterile packaging (foreign material not inside sterile packaging).
Event or Problem Description
Additional information received states that no surgical delay was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination found a hair between the seal tab and the tyvek package, confirming the reported allegation, however the device was further sent to depuy ireland for investigation and the sterility of the device was not compromised.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: depuy synthes quality system raised nc# nr-0194709 to address the current complaint condition.1) quantity manufactured: (b)(4).2) date of manufacture: 20-dec-2022.3) any anomalies or deviations identified in dhr: none.4) expiry date: 30 november 2032.5) ifu reference: ifu: 090200829.Device history review: depuy synthes quality system raised nc# (b)(4) to address the current complaint condition.1) quantity manufactured: (b)(4).2) date of manufacture: 20-dec-2022.3) any anomalies or deviations identified in dhr: none.4) expiry date: 30 november 2032.5) ifu reference: ifu: 090200829.

• Brand Name: ATTUNE RP TIB BASE SZ 3 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16251827
• Report Number: 1818910-2023-02123
• Device Sequence Number: 14825340
• Product Code: NJL
• UDI-Device Identifier: 10603295492153
• UDI-Public: 10603295492153
• 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
• Report Date (Section B): 01/27/2023

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: 1506-80-003
• Device Catalogue Number: 150680003
• Device Lot Number: 4004722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 02/20/2023; 05/04/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/21/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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