MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIVAC L; MIXER CEMENT FOR CLINICAL USE

Model Number N/A

Device Problems Failure to Pump (1502); Unclear Information (4052)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that once the device was linked to the vacuum, it was not possible to obtain a negative pressure.

Manufacturer Narrative

(b)(4).The device will not returned to the manufacturer.Therefore it could not be analyzed the device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to the available data, the exact root cause of the event cannot be determined following the investigation results of this complaint, no corrective action has been performed.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 once the device was linked to the vacuum, it was not possible to obtain a negative pressure.

• Brand Name: OPTIVAC L
• Type of Device: MIXER CEMENT FOR CLINICAL USE
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8151378
• MDR Text Key: 130050352
• Report Number: 3006946279-2018-00383
• Device Sequence Number: 1
• Product Code: JDZ
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 4152
• Device Lot Number: 0001137236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1