MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40G; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

It was reported that the outer packaging of bone cement was complete, but there was leakage of powder and the inner sterile packaging was opened.Issue noticed before surgery.

Event Description

It was reported that the outer packaging of bone cement was complete, but there was leakage of powder and the inner sterile packaging was opened.The issue was noticed before surgery.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : d4, e1, g1-2, g4, h2, h3, h6, h7, h10.H7 - corrective action has been initiated for the reported issue.The device was not returned to the manufacturer.Therefore it could not be analyzed.The pictures received show that the cement powder has leaked from the inner pouch.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address 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 CEMENT R 1X40G
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8240411
• MDR Text Key: 132929137
• Report Number: 3006946279-2018-00428
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 3003940001
• Device Lot Number: B711BB0706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1