MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 3003940001-3

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(4).The device will not be returned to the manufacturer.Therefore it will not be analyzed.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.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.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 was reported that the inner sterile packaging was opened during the operation, the doctor used a spare bone cement to complete the operation.No adverse events have been reported as a result of the malfunction.

Event Description

It has been reported that the inner sterile packaging was found opened during the operation, the doctor used a spare bone cement to complete the operation.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 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.4 complaints have been recorded on refobacin bone cement r 1x40-3, reference (b)(4), batch a927ba1601.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.A customer letter will be send regarding the 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.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• 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: 10366334
• MDR Text Key: 207338201
• Report Number: 3006946279-2020-00140
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922613
• UDI-Public: 4040029922613
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 3003940001-3
• Device Lot Number: A927BA1601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65