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

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

This user facility is outside of the united states.The necessary manufacturing history to review was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Zimmer biomet (b)(4) and packaging supplier are in the process of initiating modifications.The following sections could not be completed with the limited information provided: device info - expiration date ni.Manufacture date ¿ ni.

Event Description

It was reported that when box of bone cement was opened, the powder was leaking from the packaging.There was no patient involvement and no delay in a procedure as a result of the event.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.An investigation of the complaint has been performed consisting of a documentary review.The review of manufacturing dhr shows that products were manufactured according to the pre-defined specifications.According to the available data and as the product has not been returned for inspection, the exact root cause of the incident cannot be determined.Corrective action has been initiated for the reported issue.(b)(4).

• Brand Name: REFOBACIN BONE CEMENT R 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: elisabeth plane ; plateau de lautagne bp75; valence cedex ; 0334757591
• MDR Report Key: 5800060
• MDR Text Key: 49746111
• Report Number: 3006946279-2016-00233
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

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: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 3003940001
• Device Lot Number: A535BB2406
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2015
• 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