MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 40X1; BONE CEMENT, ANTIBIOTIC

Catalog Number 4003940001

Device Problems Unsealed Device Packaging (1444); Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign- event occurred in (b)(6).The device was not returned, therefore no product evaluation has been performed.Device history record (dhr) was reviewed and no discrepancies were found.Investigation is ongoing.If any further information is found which would change or alter any conclusions or information, a supplemental will be performed accordingly.

Event Description

It was reported that when box of bone cement was opened, the inner package was not fully sealed and the aluminium pouch was missing.There was no patient injury and no delay in the surgery.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device has been returned to the manufacturer.After evaluation it has been that the inner sterile packaging was damaged.The device history record has been reviewed.No discrepancies were found.However, a corrective action has been initiated to address the damaged inner sterile packaging issue.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: REFOBACIN BONE CEMENT R 40X1
• 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: helene bataille ; plateau de lautagne bp75; valence 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 7450049
• MDR Text Key: 106263123
• Report Number: 3006946279-2018-00146
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 4003940001
• Device Lot Number: A702AB0707
• Other Device ID Number: (01)07350023775120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1