MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).Report source, foreign ¿ event occurred in (b)(6).Combination product ¿ yes.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the cement caught fire during the cementing process.Extreme heat developed six minutes post mixing process and caused the patient drape to catch fire.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.It should be noted, in the instruction for use of the device it is written that the monomer component is a volatile and flammable substance.As long as the cement is not fully hardened, there is still a small amount of the volatile and flammable monomer available in the surrounding air.However, root cause was unable to be determined.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: OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT
• 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: 6980484
• MDR Text Key: 90343011
• Report Number: 3006946279-2017-00196
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 4720502083-1
• Device Lot Number: A707A05200
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other