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

Catalog Number 3003940001

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.However, a 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.

Event Description

It has been reported that during the surgery, the bone cement was found the outer packing of the bone cement was normal and intact, but the top sealing of the internal sterilization package was opened before surgery.

Manufacturer Narrative

(b)(4).The following sections were updated:d4-d5-e1-g1-2-g4-h2-h6-h10 the device was not returned to the manufacturer.Therefore it could not be analyzed.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.

Event Description

It was been reported that during the surgery, it was found that the outer packaging of the bone cement was normal and intact, but the top sealing of the internal sterile package was opened.The product was not used.No adverse event was reported.

• 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: 8169352
• MDR Text Key: 130498348
• Report Number: 3006946279-2018-00404
• 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: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 3003940001
• Device Lot Number: A708BB0707
• 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