MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC REFOBACIN BONE CEMENT R 80; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem No Flow (2991)

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

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

Current information in insufficient to permit a conclusion as the cause of the event.Udi: (b)(4).

Event Description

It was reported that the monomer would not release into the cartridge.No patient injury or significant delay was reported as a result of the event.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The product inspection reveals that the system is not airtight.No non-conformity has been detected.The dry mixing has not been done before the vacuum.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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 REFOBACIN BONE CEMENT R 80
• 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: 6182626
• MDR Text Key: 62682155
• Report Number: 3006946279-2016-00470
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 4712500398-1
• Device Lot Number: A604A11470
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1