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

Catalog Number 4710500394-1

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Investigation results concluded that the product is conform and the root cause is undetermined.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 the liquor didn´t leave the bag.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The device evaluation was performed, the returned product is an optipac with two pouches.The pouches were punctured but did not empty.The plunger was still locked in lower position, when the vaccum test was applied and we noticed that the system was tied, the pouches did not empty.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.No similar complaints have been recorded for optipac-s 40 refobacin bone cement r, reference (b)(4), batch a716d02310 on the reported issue.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 report will be field accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the liquid didn´t leave the bag.No adverse events have been reported as a result of the malfunction.

• Brand Name: OPTIPAC-S 40 REFOBACIN BONE CEMENT 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
• MDR Report Key: 8357011
• MDR Text Key: 136854986
• Report Number: 3006946279-2019-00108
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 03599870112212
• UDI-Public: (01)03599870112212
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 4710500394-1
• Device Lot Number: A716D02310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1