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

Model Number 4011630001

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

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 Description

It was reported that the cement was not solidified after mixing it up during the surgery.(it was solidified 2 hours later.).

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 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
• 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 Key: 8563905
• MDR Text Key: 145117602
• Report Number: 3006946279-2019-00246
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 07350023774307
• UDI-Public: (01)07350023774307
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1