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).Unique identifier (udi) #: (b)(4).Report source, foreign: event occurred in (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The review of the device manufacturing quality record indicates that (b)(4) products designation refobacin bone cement r 1x40-3, reference (b)(4), 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.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 of the powder, this one torn at the seal level.It was impossible to take off the pouch in sterile manner.There was no patient involvement, no adverse events have been reported as resultant of the malfunction.

Event Description

It was reported that during the opening of the packaging of the powder, this one torn at the seal level.It was impossible to take off the pouch in sterile manner.There was no clinical consequence.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to correct information and to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.The reported event could not be confirmed.The review of the device manufacturing quality record indicates that 2 708 products designation refobacin bone cement r 1x40-3, reference: (b)(4), 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 event described in the complaint.No other complaint has been recorded for this issue for refobacin bone cement r 1x40-3, reference: (b)(4), lot number: 835bae0303 within one year.With the available information, the exact root cause of the event could not be determined.A summary of the investigation was sent to the complainant.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.

• 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
• MDR Report Key: 9075857
• MDR Text Key: 216596387
• Report Number: 3006946279-2019-00401
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was 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 Expiration Date: 07/31/2021
• Device Catalogue Number: 3003940001-3
• Device Lot Number: 835BAE0303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1