MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN REVISION 1X40G; BONE CEMENT, ANTIBIOTIC

Model Number	4011630001
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).A sample of the same lot number has been analyzed.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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.
Event or Problem Description
It was reported that the cement was not solidified after mixing it up during the surgery.(it was solidified 2 hours later.).
Additional Manufacturer Narrative
(b)(4).This follow-up report is being filled to relay additional information.The following sections were updated: b5, d4, d10, g4, h1, h2, h3, h6, h10.The product was returned and lab analysis was performed.However the returned product was already hard so it was not possible to assess the cement behavior.A sample of the same lot number has been analyzed.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 1822 products refobacin revision 1x40g, reference (b)(4) , lot number a709ck0104 were manufactured on(b)(6)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.No other similar complaint has been recorded over the batch number a709ck0104 within one year.According to available data, the exact root cause can¿t be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
Event or Problem Description
It was reported that the cement was not solidified after mixing it up during the surgery.(it was solidified 2 hours later).No delay was reported, another cement has been used.No known adverse event was reported.

• Brand Name: REFOBACIN REVISION 1X40G
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8563905
• Report Number: 3006946279-2019-00246
• Device Sequence Number: 2065642
• Product Code: MBB
• UDI-Device Identifier: 07350023774307
• UDI-Public: (01)07350023774307
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 4011630001
• Device Catalogue Number: 3011630001
• Device Lot Number: A709CK0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1