MAUDE Adverse Event Report: REFOBACIN BONE CMNT R 1X40 JP; BONE CEMENT, ANTIBIOTIC

Catalog Number 110035373

Device Problems Unsealed Device Packaging (1444); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product.(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that this cement could not be used due to a defective packaging seal on the polymer pouch.No adverse event has been reported as a result of the malfunction.

Event Description

It was reported that this cement could not be used due to a defective packaging seal on the polymer pouch.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No further information provided (x-rays, surgical report, photographs, lab test).A complaint extract was done regarding outer pouch_difficult to open: to date (26-oct-2021), 2 complaints (involving 3 products), this one included, have been recorded regarding the brand rbcr jp, since ever.To date (26-oct-2021), 1 complaint (involving 1 product), this one included, has been recorded regarding refobacin bone cement r 1x40 jp, reference 110035373, batch 002aac1603, since ever.The product was returned and lab analysis was performed.The product analysis has shown that the outer pouch could not be opened correctly : it was noticed that this package was torn.Indeed, the supplier hangs too much which tears the paper back of the pouch.Therefore, the reported event was confirmed.Investigation results concluded that the reported event was due to packaging issue (sealing process).Corrective action has been initiated to address the reported issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: REFOBACIN BONE CMNT R 1X40 JP
• Type of Device: BONE CEMENT, ANTIBIOTIC
• MDR Report Key: 12391470
• MDR Text Key: 270514015
• Report Number: 3006946279-2021-00143
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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 Expiration Date: 11/30/2021
• Device Catalogue Number: 110035373
• Device Lot Number: 002AAC1603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2020
• 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