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

Catalog Number 3095040

Device Problems Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

Problem when opening the cement, the paper is glued with the inside of the box and desterilized.

Manufacturer Narrative

Product complaint (b)(4).B3: date of event is an unknown date.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.Dmf# - 13704 trade name ¿ gentamicin sulphate active ingredient(s) ¿ gentamicin sulphate dosage form ¿ powder strength ¿ 1.0g active in our cements 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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: problem when opening the cements.The paper is glued with the inside of the box and desterilise the product was not returned to depuy synthes.However, photos were provided for review.The photo investigation revealed, the foil pouch was opened.Leading to damage in the secondary pouch, as this had been partially sealed into the foil pouch top seal.The issue identified, during investigation can be attributed to a manufacturing issue.The sterility of the product cannot be confirmed, prior to opening the package.However, due to not being possible to properly open de product, due to issue identified.The reported allegation will be confirmed.As the device was not returned, an as-received condition could not be assessed.And a 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 investigation findings, the potential cause is traced to manufacturing.The product issue has been 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 nc was raised to address the current complaint condition.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18317952
• MDR Text Key: 330376390
• Report Number: 1818910-2023-25240
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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
• Report Date: 12/13/2023

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: 4118824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1