MAUDE Adverse Event Report: REFOBACIN BONE CEMENT R 1X40-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 3003940001-3

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/01/2021

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 after opening the outer package of bone cement during the operation, it was found that the sterile package was broken and white powder leaked, which was bc corner.In addition it was reported that the product will not be return because of customs regulations.As reported, there is a patient involvement.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.Pictures have been received.The reported event was confirmed as it can be seen that the inner cement pouch sealing is damaged and that cement powder leaked outside the inner pouch.The product analysis can't be performed as the product was not returned.The complaint is related to a well-known event, previously evaluated and investigated.No further investigation is required as per 21 cfr part 820.198 complaint files §(b) and (c).Investigation results concluded that the reported event was due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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.

Event Description

It was reported that after opening the outer package of bone cement during the operation, it was found that the sterile package was broken and white powder leaked.In addition it was reported that the product will not be returned because of customs regulations.As reported, there is a patient involvement.No adverse event has been reported as a result of the malfunction.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• Type of Device: BONE CEMENT, ANTIBIOTIC
• MDR Report Key: 12487224
• MDR Text Key: 272996096
• Report Number: 3006946279-2021-00157
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 3003940001-3
• Device Lot Number: A925CA2503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 67