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

Catalog Number 3003940001-3

Device Problems Unsealed Device Packaging (1444); Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

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 indicates that (b)(4) products designation refobacin bone cement r 1x40-3, reference 3003940001-3, lot number 835bae0303 were manufactured on 16 november 2018. The device manufacturing quality record 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. The reported event was unable to be confirmed as the product was not returned. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. According to the 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 has been reported that during the opening of the packaging, it was torn at the seal level, there was no patient involvement, no adverse events have been reported as résultat of the malfunction.

• 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
• 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: 9075799
• MDR Text Key: 195600898
• Report Number: 3006946279-2019-00400
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (Y/N): N
• Reporter Country Code: FR
• 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: PHARMACIST
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/17/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 3003940001-3
• Device LOT Number: 835BAE0303
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 11/16/2018
• 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