MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 6 4MM; KNEE FEMORAL ACCESSORY

Catalog Number	154906001
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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile augment packaging was not sealed on one end.The package was not breached; it was never sealed.There was no delay in the case, no broken instruments, no adverse events.Doe: (b)(6) 2025, affected side: unknown knee.
Additional Manufacturer Narrative
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.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: according to the information received, ¿it was reported that the sterile augment packaging was not sealed on one end.There was no delay in the case, no broken instruments, no adverse events¿.The attune pos fem aug sz 6 4mm (lot.M9130h) was not returned to medtech orthopaedics, however photos were provided for review.(b)(4) device package photo ad (b)(6) 2025".All available evidence and information was forwarded to the manufacturer for further investigation.Review of the photographic evidence revealed that the outer pouch of the dual pouch sterile barrier system was unsealed.No other defects that could have contributed to the reported event were observed.Based on the investigation performed by the manufacturer, the assignable cause of the reported complaint condition is human error categorized as an omission error.Additionally, it is worth noticing that the product is packaged in a pouch-in-pouch configuration where the outer pouch acts as a secondary sterile barrier while the inner pouch, the pouch which is in direct contact with the product, acts as the primary sterile barrier.The primary sterile barrier was maintained and was not breached, indicating that the product would be acceptable for use.The overall complaint was confirmed as the observed condition of the attune pos fem aug sz 6 4mm would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopaedics 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: nr was raised to address the reported complaint condition.

• Brand Name: ATTUNE POS FEM AUG SZ 6 4MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• 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: 22440257
• Report Number: 1818910-2025-11600
• Device Sequence Number: 19981781
• Product Code: JWH
• UDI-Device Identifier: 10603295383079
• UDI-Public: (01)10603295383079(17)20350331(10)M9130H
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 154906001
• Device Lot Number: M9130H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 111 KG