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 02/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that during the procedure, two optipac systems failed.The fluid wasn't released from the pouches.The vacuum was good.

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 two products analysis.The complaint samples were evaluated and the reported event was confirmed.The products analysis shows that for one of the product the top wasn't well screwed and for the other, the plunger was unlocked, 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), batch a726e03425 were manufactured on 14th september 2017.No non conformity or deviation was identified related to the described event.1 complaint has been recorded for optipac-s 60 refobacin bone cement r, reference (b)(4), batch a726e03425 within one year.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.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 some device elements were not accurately placed.According to available data, the most probable root cause is a handling error.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 during the procedure, two optipac systems failed.The fluid wasn't released from the pouches even if the vacuum was good.A third system was used to proceed.No adverse events have been reported as a result of the malfunction.

• 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: 8385633
• MDR Text Key: 137720224
• Report Number: 3006946279-2019-00165
• 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
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A726E03425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1