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U.S. Department of Health and Human Services

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

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BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4). (b)(6). (b)(4). Corrective action has been initiated for the reported issue.

 
Event Description

It was reported that when the box of bone cement was opened, the inner sterile packaging was found to be damaged, and the powder trickled out of the package. There was no patient injury and no delay in a procedure as a result of the event.

 
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Brand NameREFOBACIN BONE CEMENT R
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 Key6829544
MDR Text Key83982219
Report Number3006946279-2017-00145
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 10/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date10/31/2018
Device MODEL NumberN/A
Device Catalogue Number4011630001
Device LOT NumberA545AH1412
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/07/2016
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

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