MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 DEPUY CMW 1G 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3315040

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).G4: no 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.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 Description

The incident occurred on tuesday, march 5, during a total knee prosthesis at hospital.The second bag of the packaging of the powder component was open, so it did not preserve its sterility and could not be used so it did not affect the patient.

Event Description

Additional information was received and it was stated that there was no surgical delay.They used another piece.

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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.8-apr-2024 : no device associated with this report was received for examination.According to the information received, ¿the incident occurred on (b)(6) during a total knee prosthesis at hospital.The second bag of the packaging of the powder component was open, so it did not preserve its sterility and could not be used so it did not affect the patient.¿ lot: 3696927; release date: 13 may 22; expiry date: 31 dec 24; quantity: (b)(4).Please perform a manufacturing investigation for the following device as per event description: the incident occurred on tuesday, march 5, during a total knee prosthesis at hospital.The second bag of the packaging of the powder component was open, so it did not preserve its sterility and could not be used so it did not affect the patient.As the cause of this potentially a manufacturing error, a non-conformance has been raised.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 incident occurred on (b)(6), during a total knee prosthesis at hospital.The second bag of the packaging of the powder component was open, so it did not preserve its sterility and could not be used so it did not affect the patient.As the cause of this potentially a manufacturing error, a non-conformance has been raised.

• Brand Name: DEPUY CMW 1G 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool ; UK
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19004932
• MDR Text Key: 338994845
• Report Number: 1818910-2024-05785
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 3315040
• Device Lot Number: 3696927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 03/27/2024; 05/20/2024
• Supplement Dates FDA Received: 04/08/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1