MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40G; BONE CEMENT, ANTIBIOTIC

Catalog Number 3003940001

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign, event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicate that 2.615 products designation refobacin bone cement r 40x1, reference (b)(4), batch a750cd0910 were manufactured on (july 16, 2018).The device manufacturing quality record ((b)(4)) 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 complaint issue (complaint category inner sterile pouch open sealing) event described in the complaint.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.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 is found that the inner sterile packaging is opened during the surgery.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that it was found that the inner sterile packaging is opened during the surgery.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated: g4, h2, h6, h10.The received pictures can't be confirmed the reported event.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality record indicates that 2.615 products designation refobacin bone cement r 40x1, reference 3003940001, batch a750cd0910 were manufactured on (july 16, 2018).The device manufacturing quality record (6347605) 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 complaint issue (complaint category inner sterile pouch open sealing) event described in the complaint.14 complaints have been reported over the batch number a750cd0910.Corrective action has been initiated to address reported issue.A customer letter will be sent to the complainant in order to explain the issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

• Brand Name: REFOBACIN BONE CEMENT R 1X40G
• 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: 9509160
• MDR Text Key: 177941122
• Report Number: 3006946279-2019-00554
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 3003940001
• Device Lot Number: A750CD0910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1