MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410207
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when opening the first packaging of the implant, it was noticed that the second packaging was in poor condition.The seal was not breached.Another implant was used to proceed with the procedure.There was a five (5) minutes of surgical delay.The procedure was successfully completed.There was no patient consequence.
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.Additional narrative: h3, h6: product investigation: the product was returned to medtech orthopaedics for evaluation.Visual analysis of the attune ps fem rt sz 7 cem package found that both blister packaging were slightly deformed/warped, causing a difficulty to open the tyvek lid of the second blister.Primary tyvek lid of device had evidence of opening and some adhesive debris.Although the packaging was returned in a deformed/warped condition, evidence suggests the device had been sealed and packaged correctly at the manufacturer prior to when it was opened by customer.Therefore, no evidence suggests an error in the manufacturing that could be a contributing factor in the reported allegation.Per a previous data review activity completed in q1 2023 related to deformed/melted blister packaging, the potential cause of the deformed/melted blister packaging, cannot be traced to manufacturing or other jnj controlled facilities through which finished goods are distributed.Once the product leaves medtech orthopaedics control, it is unknown what environmental/external factors the finished goods products are exposed to.Therefore, the suspected cause is traced to exposer to extreme temperature conditions outside of medtech orthopaedics control.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune ps fem rt sz 7 cem would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage, and 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 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.A search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FEM RT SZ 7 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20694871
• Report Number: 1818910-2024-23882
• Device Sequence Number: 6583153
• Product Code: JWH
• UDI-Device Identifier: 10603295041788
• UDI-Public: (01)10603295041788(17)340430(10)4456406
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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

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: 150410207
• Device Lot Number: 4456406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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: Male