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 10/17/2018

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.

Event Description

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

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : device identification, initial reporter name and address, initial reporter health professional, mfr site, report source, date received by mfr, follow up type, device evaluated by mfr, evaluation codes, remedial action initiated, additional narrative.Remedial action initiated- corrective action has been initiated for the reported issue.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.Investigation showed that the most probable root cause was related to manufacturing.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.

• 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: 8240376
• MDR Text Key: 132926383
• Report Number: 3006946279-2018-00412
• 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: 05/24/2019

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 3003940001
• Device Lot Number: A746BA1504
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1