MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40G; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 was reported that the inner sterile packaging is opened in the side of the b before the surgery.There was no patient involvement.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures and documents.The device was not returned to the manufacturer.Therefore it could not be analyzed.An investigation has been performed, consisting of a documentary review.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.A capa (ca-03756) has been initiated in order to implement actions to avoid the recurrence of this type of issue.According to available data, the most probable root cause is due to packaging issue (sealing process).This complaint could be reopened if further information is received later.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 was reported that the inner sterile packaging is opened in the side of the b before the surgery.One product was involved in the event.There was no patient involvement.No adverse events have been reported as a result of the malfunction.

• Brand Name: REFOBACIN BONE CEMENT R 1X40G
• 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: 9277196
• MDR Text Key: 217124583
• Report Number: 3006946279-2019-00466
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 3003940001
• Device Lot Number: A749DC0513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR