MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

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 monomer was not entering into the cartridge.

Event Description

It was reported that the monomer was not entering into the cartridge.

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.The complaint device was returned and was evaluated.Although the complaint related a monomer not entering into the cylinder, the product analysis showed that the plunger was unlocked and that the monomer liquid leaked out of the pouches when the blue handles were impacted.The product analysis therefore showed that the event was related to a plunger issue.With the available information, the exact root cause of the unlocked plunger could not be determined.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: OPTIPAC 80 REFOBACIN BONE CEMENT R-3
• 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: 8240353
• MDR Text Key: 132927654
• Report Number: 3006946279-2018-00438
• 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: 08/01/2019

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: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 4712500398-3
• Device Lot Number: 743AA06450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1