MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 7 CEM; KNEE TIBIAL TRAY

Catalog Number	150670007
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	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: 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 there was a packaging issue: absence of a tear allowing the double packaging to be gripped.The device in question was placed in the patient.The complaint is made after use to indicate the absence of a handling label.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary packaging issue: absence of a tear allowing the double packaging to be gripped).The product was not returned to depuy synthes; however, photos were provided for review.See attachment img_2572, img_2571, img_2573.The depuy synthes team forwarded the photos of the complaint unit to the manufacturing site depuy cork for a manufacturing investigation.The photo investigation revealed that the tyvek lid does not contain the lift label, confirming the reported allegation.Based on the manufacturing investigation, it was determined that this complaint did not originate within the cork-depuy synthes manufacturing process and it was categorized as a supplier related nonconformance.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 7 cem would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: supplier (b)(4) was opened to document investigation of the assignable cause associated with this complaint.

• Brand Name: ATTUNE FB TIB BASE SZ 7 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23426765
• Report Number: 1818910-2025-18644
• Device Sequence Number: 8253663
• Product Code: JWH
• UDI-Device Identifier: 10603295492092
• UDI-Public: (01)10603295492092(17)350731(10)4916269
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K233986
• 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

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 Catalogue Number: 150670007
• Device Lot Number: 4916269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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