MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40 US; BONE CEMENT, ANTIBIOTIC

Model Number 110034355

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product (b)(4).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 during placement of cement on tibia, with the tibia subluxed and soft tissues protected, bovie cauterization (electrosurgical cauterization) was utilized in the medial parapatellar area.At this point, an assistant noticed at the center part of the cement, that a low flame was noted, was tamped, put out immediately glowing on surface of cement.The cement was removed.The wound was copiously irrigated once again.Witnessed no tissues compromised or flame adjacent to tissues.Cementing technique was performed.The implants were put in atraumatically.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported, that during placement of cement on tibia, with the tibia subluxed and soft tissues protected, bovie cauterization (electrosurgical cauterization) was utilized in the medial parapatellar area.At this point, an assistant noticed at the center part of the cement, that a low flame was noted, was tamped, put out immediately glowing on surface of cement.The cement was removed.The wound was copiously irrigated once again.Witnessed no tissues compromised or flame adjacent to tissues.Cementing technique was performed.The implants were put in atraumatically.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This is a combination product (b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.Complaint history identified no other similar event for the reported item and part/lot combinations.The root cause of the reported issue is attributed to user.It was reported the use of electrocautery devices in surgical sites near freshly implanted bone cement.Ifu requires to adequately ventilate the operating room to eliminate as much monomer vapor as possible.The liquid monomer is highly volatile and flammable.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: REFOBACIN BONE CEMENT R 1X40 US
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13141116
• MDR Text Key: 283077270
• Report Number: 3006946279-2022-00002
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: 00880304990197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 110034355
• Device Catalogue Number: 110034355
• Device Lot Number: Z50BAK2305
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1