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).(b)(6).The device has been returned to the manufacturer.After evaluation it has been seen that the inner sterile packaging was damaged.The packaging missing event could not been confirmed.Indeed, the device history record has been reviewed.No discrepancies were found.With the available information, the exact root cause of the event could not be determined.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.

Event Description

It was reported that the aluminium pouch was missing.There was no patient injury and no delay in the surgery.However, after product reception and evaluation on 25 june 2018, it has been discovered that the inner sterile packaging was damaged.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Evaluation of returned device found the supplier sealing was opened in 1 area.The manufacture sealing was intact.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to product design.Corrective action has been initiated to address reported issue.The missing packaging event described in the complaint was investigated, and this event could not be confirmed.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.

Event Description

Please refer to 3006946279-2018-00231.

• 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
• MDR Report Key: 7771728
• MDR Text Key: 116708402
• Report Number: 3006946279-2018-00231
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1