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

Catalog Number 3003940001-3

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product (b)(4).Report source, foreign - event occurred in (b)(6).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.

Event Description

It was reported that the cement powder leaked out through the unsealed bottom packaging upon removing it from the unsterile packaging.No adverse health consequence has been reported as the result of the malfunction.

Manufacturer Narrative

(b)(4).Pictures have been received.It can be seen that the inner cement pouch sealing is damaged.The product was returned and lab analysis was performed.The product has been returned in original box with all pouches.On the inner pouch, the left sealing is opened on all of the length, and on 2/3 of the length on the long supplier sealing.The biomet sealing is not damaged.The complaint is related to a well-known event, previously evaluated and investigated.No further investigation is required as per 21 cfr part 820.198 complaint files §(b) and (c).Investigation results concluded that the reported event was 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 was reported that the cement powder leaked out through the unsealed bottom packaging upon removing it from the unsterile packaging.No adverse health consequence has been reported as the result of the malfunction.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• Type of Device: BONE CEMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12561798
• MDR Text Key: 275245435
• Report Number: 3006946279-2021-00162
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1