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

Model Number N/A

Device Problem Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the information provided: return expected, not yet received.

Event Description

It was reported that when box of bone cement was opened, paper particles from box remained on cement packages.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.Examination of returned device found that some particles were visible on the external surface of the breather bag, confirming the event.The carton is not damaged and not opened.No particles were visible on the internal surface of the breather bag.Review of device history records show that lot released with no recorded anomaly or deviation.This is a single occurrence.Root cause of the event was most likely attributed to the packaging process.However, a conclusive root cause of the event could not be determined.(b)(4).

• Brand Name: OPTIPAC-S 40 REFOBACIN BONE CEMENT R
• 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: 5698926
• MDR Text Key: 46566199
• Report Number: 3006946279-2016-00102
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 4710500394-1
• Device Lot Number: A534A04770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• 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