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

Catalog Number 3095040

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 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Dmf# - 13704.Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form ¿ powder.Strength ¿ 1.0g active in our cements.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 sterile packaging containing the product (powder) was damaged when the outside was opened.They were sealed together and when the one on the outside was opened, the one on the inside that contained the cement was automatically opened.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary according to the information received, the sterile packaging containing the product (powder) was damaged when the outside was opened.They were sealed together and when the one on the outside was opened, the one on the inside that contained the cement was automatically opened.The product was not returned to depuy synthes, however photos were provided for review.See attachment "(b)(4)".The photograph attached was reviewed, however they do not represent the reported complaint condition.The photo only shows the part and lot number and no other observation pertaining to the nature of the reported event could be identified.However based on the investigation performed by the manufacturing site, the root cause of the reported condition was traced to a manufacturing issue.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed based on the available information.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 - a manufacturing record evaluation was performed for the finished device [(b)(6)] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.However, an nc was initiated to address current complaint condition.

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.H10 additional narrative: added: b5, h4.

Event Description

Additional information was received and states that there were no patient consequences.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork IN ; 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 ; 3035526892
• MDR Report Key: 18440925
• MDR Text Key: 331937024
• Report Number: 1818910-2024-00306
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: PO
• 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
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• 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: 4147061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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