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

Model Number N/A

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the monomer liquid would not flow into the chamber.There was not a hole for the cement to come out of and it felt as if there was no needle to puncture the cement bag(s).A delay of 15 minutes was reported.The surgery was completed with another batch.No additional patient consequence or further information have been reported.

Manufacturer Narrative

(b)(4).The device has not been returned, therefore no product evaluation has been performed.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that there is no non-conformity.If any further information is found which would change or alter any conclusions or information, a supplemental will be performed.

• Brand Name: OPTIPAC-S 40 REFOB BN CMT 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: helene bataille ; plateau de lautagne bp75; valence cedex, IN 26903 ; FR 26903 ; 5745273773
• MDR Report Key: 7009965
• MDR Text Key: 92324863
• Report Number: 3006946279-2017-00234
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 4710500394-1
• Device Lot Number: A633A04240
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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