MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 6 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611006
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
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.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
Unable to take out tibial implant from packaging.Plastic packaging was deformed/melted and broke on attempt to take out implant.
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 that 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.H11 additional narrative: corrected: b3.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: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Additional information received states that the issue was not the implant itself, but the packaging it came in which has already been discarded by the customer.There was no issue with the implant.It was not implanted into the patient because the packaging was too difficult to open but the packaging (the origin of the product complaint) had been discarded on the day of the case.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: unable to take out tibial implant from packaging.Plastic packaging was deformed/ melted and broke on attempt to take out implant the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment ((b)(4) image 2).Photo investigation revealed that both blister packaging were deformed/warped, causing a difficulty to open it and to retrieve devices from packaging.Furthermore, based on the severely warped condition of the blisters, it is not unreasonable to suspect that the seal between the blister and the tyvek lid was breached, compromising the sterility of the product inside.Based on the nonconformance search, there is no evidence suggesting that damage had occurred during the manufacturing process.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.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 rp tib base sz 6 por would contribute 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.Device history lot: a search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ATTUNE RP TIB BASE SZ 6 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19973238
• Report Number: 1818910-2024-17300
• Device Sequence Number: 18250834
• Product Code: NJL
• UDI-Device Identifier: 10603295416289
• UDI-Public: (01)10603295416289(17)340531(10)4493217
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 08/13/2024

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: 150611006
• Device Lot Number: 4493217
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 08/23/2024; 11/05/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/22/2024; 08/28/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• 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