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

Model Number N/A

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

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

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see reports: 3006946279 - 2018 - 00007.Report source- foreign.The event occurred in (b)(6).Pma 510(k): - 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 of two batches of cement would not enter the cannister.A 15 minute delay to surgery was reported as a result.The surgery was completed with another batch.No further information has been made available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.  the device manufacturing quality record indicates that the released product met all requirements to perform as intended.Complaint sample was evaluated and the reported event was confirmed.The returned device was evaluated and the device cannula was blocked by a plug of cement, which prevented the monomer to flow inside the device cylinder.Investigation results concluded that the reported event was likely due to an handling error.  if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was been reported that the monomer liquid of the optipac from two different batches would not enter the optipac cylinder.A 15 minute delay to surgery was reported as a result.The surgery was completed with a product from another batch.

• Brand Name: OPTIPAC 40 REFOBACIN BONE CEMENT
• 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: 7175036
• MDR Text Key: 96834065
• Report Number: 3006946279-2018-00006
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4710500394-1
• Device Lot Number: A65D05170
• Other Device ID Number: (01) 03599870112212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1