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

Model Number N/A

Device Problem Device Packaging Compromised (2916)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Combination product ¿ yes.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the inner sterile packaging was damaged.The dust bag of bone cement was not completely sealed.The outer box was completely closed.A delay of 15 minutes was reported.No further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Evaluation of returned device found the left supplier sealing was opened on all the length.The manufacturer sealing was intact.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to supplier packaging issue.Corrective action has been initiated to address reported issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filled accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the inner sterile packaging leaked.There was no patient involvement.

• 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
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: bataille hélène ; plateau de lautagne bp75; valence cedex, IN 26903 ; 5745273773
• MDR Report Key: 6980530
• MDR Text Key: 90952446
• Report Number: 3006946279-2017-00197
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/26/2018

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 4011630001
• Device Lot Number: A545AI2903
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• 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