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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 2X40-3; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 2X40-3; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 3003940002-3
Device Problems Improper Chemical Reaction (2952); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The review of the device manufacturing quality record indicates that 3204 products refobacin bone cement r 2x40g, reference 3003940002-3, lot number 833cae0303 were manufactured on 31 october 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.With the available information, the exact root cause of the event 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.
 
Event Description
It has been reported that the material manager of the operating room received a defective refobacin bone cement, the powder does not mix with the liquid.They had to use another cement sprayer to finish the procedure.
 
Manufacturer Narrative
(b)(4).This follow-up report is being filled to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.However pictures were received and reviewed.The picture reviewed showed that the powder did not mix with the monomer.Indeed, in the upper part of the cylinder, the mixture was carried out.However, in lower part of the cylinder, it is possible to see powder which did not mix with the monomer liquid.Also, reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The instructions for use of the optivac products has been reviewed and it was found that the monomer liquid must be introduced in the cylinder, before the cement powder, that is not the case of the product in pictures.Indeed, on the picture, it is possible to see that the powder is under the monomer liquid.This could explain the difficulties to mix the cement.The review of the device manufacturing quality record indicates that 3204 products refobacin bone cement r 2x40g, reference 3003940002-3, lot number 833cae0303 were manufactured on 31 october 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint no other similar complaint has been recorded for refobacin bone cement r 2x40g, reference 3003940002-3, lot number 833cae0303 on the reported event within one year.With the available information, the most probable root cause of the event could be a handling error.A summary of the investigation was sent to the complinant conveying proper use of the device.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 the material manager of the operating room received a defective refobacin bone cement, the powder does not mix with the liquid.They had to use another cement sprayer to finish the procedure.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).This follow-up report is being filled to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.However pictures were received and reviewed.The picture reviewed showed that the powder did not mix with the monomer.Indeed, in the upper part of the cylinder, the mixture was carried out.However, in lower part of the cylinder, it is possible to see powder which did not mix with the monomer liquid.Also, reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The review of the device manufacturing quality record indicates that (b)(4) products refobacin bone cement r 2x40g, reference (b)(4), lot number 833cae0303 were manufactured on 31 october 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint no other similar complaint has been recorded for refobacin bone cement r 2x40g, reference (b)(4), lot number 833cae0303 on the reported event within one year.With the available information, the exact root cause of the event 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.
 
Event Description
It was reported that the material manager of the operating room received a defective refobacin bone cement, the powder does not mix with the liquid.They had to use another cement sprayer to finish the procedure.No adverse events have been reported as a result of the malfunction.
 
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Brand Name
REFOBACIN BONE CEMENT R 2X40-3
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 Key8959540
MDR Text Key216765582
Report Number3006946279-2019-00387
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Catalogue Number3003940002-3
Device Lot Number833CAE0303
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
OPTIVAC M, ITEM 4160
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