MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Catalog Number	129453246
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	10/30/2024
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.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: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the item arrived with broken plastic cover from the edc to the distributor's warehouse.The item was not shipped to any customer/hospital.There was no patient impact.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: item arrived with broken plastic cover from the edc to the distributor's warehouse.The item was not shipped to any customer/hospital.No patient impacts.The product was returned to j&j medtech orthopaedics for evaluation, additionally a photo was provided for review.See attachment picture1.The photo and visual inspection of the returned device found that the outer packaging of the universal fem slv ful por 46mm was damaged, the four corners of the cardboard box were deformed and the shrink-wrap plastic was torn and partially open from the bottom right side.Evidence indicates that the device had been properly sealed and packaged at the manufacturer.Consequently, there is no indication of any manufacturing error that could have contributed to the reported issue.Once the product leaves j&j medtech orthopaedics control, it is unknown what environment conditions or human intervention or manipulation the packaged products are exposed to during that time.Therefore, the suspected cause is traced to transport/storage outside of j&j medtech orthopaedics control.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device product description: universal fem slv ful por 46mm product code: 129453246 lot number: m03f20 and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the universal fem slv ful por 46mm 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: a manufacturing record evaluation was performed for the finished device product description: universal fem slv ful por 46mm product code: 129453246 lot number: m03f20 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: universal fem slv ful por 46mm product code: 129453246 lot number: m03f20 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: UNIVERSAL FEM SLV FUL POR 46MM
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• 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 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20632351
• Report Number: 1818910-2024-23301
• Device Sequence Number: 12627139
• Product Code: JWH
• UDI-Device Identifier: 10603295026365
• UDI-Public: (01)10603295026365(17)320731(10)M03F20
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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

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: 129453246
• Device Lot Number: M03F20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 11/29/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/13/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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