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

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.

• Brand Name: REFOBACIN BONE CEMENT R
• 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: 6829544
• MDR Text Key: 83982219
• Report Number: 3006946279-2017-00145
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (Y/N): N
• Reporter Country Code: SZ
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• 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 Received: 08/30/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes

Device Operator

• Device EXPIRATION Date: 10/31/2018
• Device MODEL Number: N/A
• Device Catalogue Number: 4011630001
• Device LOT Number: A545AH1412
• OTHER Device ID Number: SEE H10 NARRATIVE
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A