MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problems Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

The nurse tried to tear the cement packet, but the gap between the outer packet and the sterile packet was very close, causing the sterile packet to tear as well.Therefore, the product is contaminated and cannot be used.Was surgery delayed due to the reported event? no, action taken when event occurred? open and use the new one, was procedure successfully completed? yes, were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4) device property of none, device in possession of none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

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.Dmf# - 13704 trade name gentamicin sulphate active ingredient(s) gentamicin sulphate dosage form - powder strength 1.0g active in our cements.

Event Description

Additional information received: a.Storage temperature before using is between 20-25 degrees.B.Or temperature during using cement is between 17-22 degrees.

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.

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.

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.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: the nurse tried to tear the cement packet, but the gap between the outer packet and the sterile packet was very close, causing the sterile packet to tear as well.Therefore, the product is contaminated and cannot be used.The product was not returned to depuy synthes, however photos were provided for review.See attachment img_1792.Jpeg, img_1791.Jpeg and img_1790.Jpeg.Visual inspection of the photos revealed that the smartset ghv gentamicin 40g was found with the carboard packaging open.The package contains two (2) pouches that are not sterile, both were found tear open, therefore the sterility of the bag that contains the cement was compromised.It is worth mentioning that the secondary packaging appears to be trapped in the foil seal.Dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the smartset ghv gentamicin 40g would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: an nr was created to address current complaint condition.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, the nurse tried to tear the cement packet, but the gap between the outer packet and the sterile packet was very close, causing the sterile packet to tear as well.Therefore, the product is contaminated and cannot be used.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that the smartset ghv gentamicin 40g was found with the carboard packaging open.The package contains two (2) pouches that are not sterile, both were found tear open, therefore the sterility of the bag that contains the cement was compromised.It is worth mentioning that the secondary packaging appears to be trapped in the foil seal.A functional test was not performed as it is not applicable to the complaint condition.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the smartset ghv gentamicin 40g would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : an nr was created to address current complaint condition.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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 ; 3035526892
• MDR Report Key: 18415950
• MDR Text Key: 331705727
• Report Number: 1818910-2023-26100
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: OUS - SIMILA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/28/2023

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: 3095040
• Device Lot Number: 4047299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 12/26/2023; 01/18/2024; 03/11/2024; 03/15/2024; 03/15/2024
• Supplement Dates FDA Received: 01/08/2024; 01/22/2024; 03/14/2024; 03/15/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1