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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 1X40G; BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40G; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 3003940001
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign report source: (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 3231 products désignation refobacin bone cement r 40 ref.3003940001, batch a749dc0513 were manufactured on (17th may 2018).The device manufacturing quality record (of6306390) 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 innercement 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 during the surgery.No adverse event has been reported as a result of the malfunction.This event involves three products.
 
Event Description
It was reported that inner sterile packaging was found to be opened during the surgery.No adverse event has been reported as a result of the malfunction.This event involves three products.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.However, some photos have been recorded and can confirmed the reported event.The review of the device manufacturing quality record indicate that 3231 products désignation refobacin bone cement r 40 reference 3003940001, batch a749dc0513 were manufactured on (17th may 2018).The device manufacturing quality record (of 6306390) 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.22 complaints have been recorded over the batch a749dc0513 within one year.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.A customer letter has been sent to the customer to inform 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 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 Key9374586
MDR Text Key217335648
Report Number3006946279-2019-00509
Device Sequence Number1
Product Code MBB
UDI-Device Identifier4040029110126
UDI-Public(01)4040029110126
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
Report Date 02/13/2020
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 Date11/30/2020
Device Catalogue Number3003940001
Device Lot NumberA749DC0513
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received02/13/2020
Supplement Dates FDA Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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