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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4711500396-1
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Investigation results concluded that the product is conform and the root cause is undetermined.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 needles do not puncture the bag.
 
Event Description
It has been reported that needles did not puncture the bag.No impact patient has been reported.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.An investigation has been performed, consisting of a documentary review and a product analysis.The complaint sample was evaluated and the reported event could not be confirmed.The returned device was evaluated and was conform.The monomer pouches were punctured by the canulas.However, the top was not well screwed so the vacuum test failed.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 60 refobacin bone cement r, reference (b)(4), lot number a749b06465 were manufactured on 20 december 2017.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.3 similar complaints have been recorded for optipac-s 60 refobacin bone cement r, batch a749b06465 within one year.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.The products analysis did not show any products non conformity, but showed that the top was not well screwed.According to available data, the most probable root cause is a handling error.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions and asking customer to refer to instructions for use 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.
 
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Brand Name
OPTIPAC-S 60 REFOBACIN BONE CEMENT R
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 Key8353114
MDR Text Key136762639
Report Number3006946279-2019-00138
Device Sequence Number1
Product Code MBB
UDI-Device Identifier03599870112229
UDI-Public(01)03599870112229
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,o
Type of Report Initial,Followup
Report Date 09/06/2019
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 Date05/31/2019
Device Catalogue Number4711500396-1
Device Lot NumberA749B06465
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/21/2019
Initial Date FDA Received02/20/2019
Supplement Dates Manufacturer Received08/30/2019
Supplement Dates FDA Received09/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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