MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONUS II-5CC; ALLOGRAFT BONE

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Review of the dhr found the product was released to distribution with no deviations or anomalies.Review of the complaint history determined that no further action is required as no were trends identified.Current information is insufficient to permit conclusions as to the cause of the events.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.(b)(4).

Event Description

It was reported that during a clavicle fracture procedure the bonus demineralized bone matrix (dbm) was combined with bone marrow concentrate (bmc), dbm did not soften.The surgeon crushed the dbm and soaked it with the bmc that was left over.The resulting mixture was put into the fracture to complete the procedure.

• Brand Name: BONUS II-5CC
• Type of Device: ALLOGRAFT BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6903605
• MDR Text Key: 88150600
• Report Number: 0001825034-2017-07565
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PNOT LISTED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 48-DBM5
• Device Lot Number: 792060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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
• Patient Sequence Number: 1