MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121936058
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); 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	04/03/2024
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
It was reported that the pinnacle neutral liner appears to have had the inner packaging corner sealed within the outer packaging.This meant that when the packet was opened the second layer was also partially torn at the same time.The staff were still happy to use the liner as they determined it was still sterile so there was no delay to the surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, the pinnacle neutral liner appears to have had the inner packaging corner sealed within the outer packaging.This meant that when the packet was opened the second layer was also partially torn at the same time.The staff were still happy to use the liner as they determined it was still sterile so there was no delay to the surgery.The product was not returned to medtech orthopaedics.However, photos were provided for review.The photos were forwarded to medtech orthopaedics cork site for a manufacturing investigation.Review of the photographic evidence that the inner tyvek lid of the pinn mar neut 36idx58od was delaminated.The observed condition of the lid could suggest that the package was difficult to open.However, there is no expected impact on the sterility of unit, or the integrity of sterile barrier based on the provided evidence.Based on the provided information retrieved form the manufacturing investigation, the observed condition for the packaged cannot be trace to a manufacturing issue and no action is required.The allegation regarding the inner tyvek lid being sealed within the outer blister seal cannot be confirmed as the unit was not returned to the manufacturing site.A manufacturing record evaluation was performed for the finished device [121936058 / 4182461] and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar neut 36idx58od would contribute to the reported difficulty to open the package.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 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 manufacturing record evaluation was performed for the finished device [121936058 / 4182461] and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device [121936058 / 4182461] and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: PINN MAR NEUT 36IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19103970
• Report Number: 1818910-2024-08270
• Device Sequence Number: 12598691
• Product Code: LPH
• UDI-Device Identifier: 10603295014478
• UDI-Public: 10603295014478
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K010171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 04/15/2024

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: 121936058
• Device Lot Number: 4182461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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