MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 8 CEM; KNEE TIBIAL TRAY

Catalog Number	150670008
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	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > intraoperatively it was obvious that the inner sterile cover was glued with the outer sterile package.See photos.The implant needed to be removed with help of a scalpel.No surgical delay, no adverse patient consequences.Surgery was completed without issues.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment (b)(4) photos.Pdf.Furthermore, a manufacturing investigation was conducted by the manufacturing site j&j medtech orthopaedics cork team.The photo investigation revealed that the attune fb tib base sz 8 cem inner tyvek lid appears to be sealed to the outer tyvek lid.A manufacturing record evaluation was performed for the finished device product code: 150670008 lot number: 4556770, and there was 1 non-conformance associated with this lot, however this not related to the failure mode of the complaint.Based on the manufacturing investigation, a definitive root cause could not be determined due to insufficient evidence provided.As the complaint unit was not returned to the cork site and from the trials performed, it was indicated that there is not sufficient photographic evidence in order to determine if the complaint part meets or does not meet the internal packaging requirements.If further data or evidence become available, the investigation will be re-assessed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 8 cem would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > 1) quantity manufactured: (b)(4).2) date of manufacture: 8/25/2024 3) any anomalies or deviations identified in dhr: 1non-conformance associated with this lot, however this not related to the failure mode of the complaint.4) expiry date: 7/31/2034 5) ifu reference: ifu-0902-00-828 device history review = > a manufacturing record evaluation was performed for the finished device product code: 150670008 lot number: 4556770, and there was 1 non-conformance associated with this lot, however this not related to the failure mode of the complaint.
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.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
It was reported that intraoperatively it was obvious that the inner sterile cover was glued with the outer sterile package.The implant needed to be removed with help of a scalpel.No surgical delay, no adverse patient consequences occurred.Surgery was completed without issues.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: intraoperatively it was obvious that the inner sterile cover was glued with the outer sterile package.See photos.The implant needed to be removed with help of a scalpel.No surgical delay, no adverse patient consequences.Surgery was completed without issues.The product was not returned to j&j medtech orthopaedics; however photos were provided for review.See attachment (b)(4) photos.Pdf.Furthermore, a manufacturing investigation was conducted by the manufacturing site j&j medtech orthopaedics cork team.The photo investigation revealed that the attune fb tib base sz 8 cem inner tyvek lid appears to be sealed to the outer tyvek lid.A manufacturing record evaluation was performed for the finished device product code: 150670008 lot number: 4556770, and there was 1 non-conformance associated with this lot, however this not related to the failure mode of the complaint.This product issue has been addressed through j&j medtech orthopaedics quality system.Based on the manufacturing investigation, a definitive root cause could not be determined due to insufficient evidence provided.Trials were also complete to attempt to recreate the failure mode.From these trials, the complaint failure mode was replicable with some of the same characteristics being noted on the trial packaging, however, there is not sufficient photographic evidence in order to determine if the complaint part meets or does not meet the internal packaging requirements.If further data or evidence become available, the investigation will be re-assessed.There is no expected impact on the sterility of unit, or the integrity of sterile barrier based on the complaint investigation, as per the review of the photos provided, both sterile barriers appear to be sealed.Product under the scope of this complaint was terminally sterilized and met with acceptance criteria.The sterile barrier was not broken until it was opened at the customer.Therefore, the sterile barrier was not compromised.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 8 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 has been 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 8/25/2024.3) any anomalies or deviations identified in dhr: 1non-conformance associated with this lot; however, this not related to the failure mode of the complaint.4) expiry date: 7/31/2034.5) ifu reference: ifu-0902-00-828.Device history review: a manufacturing record evaluation was performed for the finished device product code: 150670008 lot number: 4556770, and there was 1 non-conformance associated with this lot, however this not related to the failure mode of the complaint.

• Brand Name: ATTUNE FB TIB BASE SZ 8 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: 21927380
• Report Number: 1818910-2025-06635
• Device Sequence Number: 8907284
• Product Code: JWH
• UDI-Device Identifier: 10603295492108
• UDI-Public: (01)10603295492108(17)340731(10)4556770
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K233988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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

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: 150670008
• Device Lot Number: 4556770
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 12/01/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/01/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2024
• 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