MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3092040
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during setup for the case that morning, the circulator had opened a bag of our cement and found it to be busted.I had grabbed a few boxes to replace it, but the powder packaging in all four of them was also busted.It appeared that there was an issue with the seal not closing all the way.They all had the same lot number.There had been no delay to the case or issue with the patient.
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.
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 which 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: b5, d10, h6.Corrected: d4 (primary udi number).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
Additional information received: allegations towards this product: the packaging that contains the powder for the cement was improperly sealed.
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 which 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.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: it was reported that during setup for the case that morning, the circulator had opened a bag of our cement and found it to be busted.I had grabbed a few boxes to replace it, but the powder packaging in all four of them was also busted.It appeared that there was an issue with the seal not closing all the way.They all had the same lot number.We still had five more from that same box with the same lot number that had not been opened, but i assumed they were likely defective as well and did not feel comfortable opening them.There had been no delay to the case or issue with the patient.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned smartset hv bone cement 40g revealed that the box had some crush damage at the bottom and perforations at the top have split on the left side.However, the inner package powder pack is intact and does not have any signs of leaking.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.The overall complaint was not confirmed as the observed condition of the smartset hv bone cement 40g would not contribute 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: 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.H11 additional narrative: added: g4 (pma) corrected: h3.

• Brand Name: SMARTSET HV BONE CEMENT 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19951728
• Report Number: 1818910-2024-17170
• Device Sequence Number: 15653918
• Product Code: LOD
• UDI-Device Identifier: 10603295168331
• UDI-Public: (01)10603295168331(17)250731(10)4251969
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K023012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/09/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 3092040
• Device Lot Number: 4251969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 09/26/2024; 12/19/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/13/2024; 09/28/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 86 KG