MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIVAC M; CEMENT MIXING KIT

Model Number N/A

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.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.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 has been reported that a foreign substance was found in sterilization packaging.The surgery was finished with backup product.

Manufacturer Narrative

(b)(4).The following sections were updated: g1-2- g4-h2-h10 the device history record has been reviewed.No discrepancies were found.The returned item has been inspected.According to the available data, the exact root cause of the event cannot be determined.However, this complaint could be reopened if further information is received later.

Event Description

It has been reported that a foreign substance was found in the sterile packaging.The surgery was finished with backup product.

• Brand Name: OPTIVAC M
• Type of Device: CEMENT MIXING KIT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 7536209
• MDR Text Key: 109489396
• Report Number: 3006946279-2018-00173
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 4160
• Device Lot Number: 0001255473
• Other Device ID Number: (01) 07350023771122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1