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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 20; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 20; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 3003920001
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicate that (b)(4) products désignation refobacin bone cem r 20 ref.3003920001, batch b702aa2303 were manufactured on (21th july 2017).The device manufacturing quality record (of6108015) 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 complaint issue (complaint category inner cement pouch open sealing) event described in the complaint.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
 
Event Description
It was reported that inner sterile packaging was found to be opened.This issue was detected during the surgery.This event involves 10 products.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The product has been received at the manufacturer.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
 
Event Description
It was reported that inner sterile packaging was found to be opened.This issue was detected during the surgery.This event involves 10 products.No adverse events have been reported as a result of the malfunction.
 
Event Description
It was reported that inner sterile packaging was found to be opened.This issue was detected during the surgery.This event involves 10 products.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated: b4, g4, h2, h6, h10.The product analysis show that the product has been returned in original box with the outer pouch, labels and the monomer ampoule.The inner pouch hasn¿t been returned.The event is not confirmed.The review of the device manufacturing quality record indicates that 959 products designation refobacin bone cement r 20 ref.3003920001, batch b702aa2303 were manufactured on (21th july 2017).The device manufacturing quality record (of6108015) 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 complaint issue (complaint category inner cement pouch open sealing) event described in the complaint.1 complaint has been reported over the batch number b702aa2303.According to the available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A customer letter will be sent to the complainant in order to explain the issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
 
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Brand Name
REFOBACIN BONE CEMENT R 20
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 Key9382115
MDR Text Key196087894
Report Number3006946279-2019-00519
Device Sequence Number1
Product Code MBB
UDI-Device Identifier04040029110102
UDI-Public(01)04040029110102
Combination Product (y/n)N
PMA/PMN Number
K150850
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 03/31/2020
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 Date12/31/2019
Device Catalogue Number3003920001
Device Lot NumberB702AA2303
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received11/27/2019
Supplement Dates Manufacturer Received03/04/2020
03/23/2020
Supplement Dates FDA Received03/05/2020
03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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