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

Catalog Number 3003940001-3

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device was not returned to the manufacturer yet.Therefore, it could not be analyzed yet.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The investigation is pending.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 that during the initial surgery two sterile packs of the cement of polymer powder have leaked.No adverse events have been reported as a result of the malfunction.

Event Description

It has been reported that during operation, the cement powder packet was found not sealed properly, and the powder has leaked inside the packaging.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 two products involved in the complaint have been received.The product analysis shows that on the two inner pouches, the right sealing is opened on 3/6 of the length.The reported event is confirmed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Eight complaints have been recorded on refobacin bone cement r 1x40-3, reference 3003940001-3, over the batch a925ca2503.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, ANTIBIOTICS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10703205
• MDR Text Key: 220941576
• Report Number: 3006946279-2020-00206
• Device Sequence Number: 1
• Product Code: MBB
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 3003940001-3
• Device Lot Number: A925CA2503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1