MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC

Catalog Number 4711500396-1

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was 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.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 needles do not puncture the bag.

Event Description

It has been reported that needles did not puncture the bag.No impact patient has been reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.An investigation has been performed, consisting of a documentary review and a product analysis.The complaint sample was evaluated and the reported event could not be confirmed.The returned device was evaluated and was conform.The monomer pouches were punctured by the canulas.However, the top was not well screwed so the vacuum test failed.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 60 refobacin bone cement r, reference (b)(4), lot number a749b06465 were manufactured on 20 december 2017.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.3 similar complaints have been recorded for optipac-s 60 refobacin bone cement r, batch a749b06465 within one year.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.The products analysis did not show any products non conformity, but showed that the top was not well screwed.According to available data, the most probable root cause is a handling error.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions and asking customer to refer to instructions for use 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.

• Brand Name: OPTIPAC-S 60 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: 8353114
• MDR Text Key: 136762639
• Report Number: 3006946279-2019-00138
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 03599870112229
• UDI-Public: (01)03599870112229
• 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,o
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A749B06465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1