• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40-3 BONE CEMENT, ANTIBIOTIC Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREFOBACIN BONE CEMENT R 1X40-3
Type of DeviceBONE 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 Key9075799
MDR Text Key195600898
Report Number3006946279-2019-00400
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberN/A
Number of Events Reported1
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 Received09/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3003940001-3
Device LOT Number835BAE0303
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 Received09/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/16/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

-
-