MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET BIOLOGICS MINI CTR BAL; SUPPLIES, BLOOD-BANK

Model Number N/A

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 02/05/2014

Event Type  Injury  

Event Description

It was reported patient underwent an initial procedure on (b)(6) 2014.While preparing for the procedure, the gps ii platelet machine made a popping noise and the balance fractured.A delay of over 30 minutes occurred during the procedure.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.The following sections could not be completed with the limited information provided.Expiration date - unknown.Manufacture date ¿ unknown.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Manufacturer Narrative

This follow-up report is being filed to relay correct product identification.Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted the origin of the fracture suggests the counterbalance was not in the correct carrier or not fully seated in the correct carrier.

• Brand Name: BIOMET BIOLOGICS MINI CTR BAL
• Type of Device: SUPPLIES, BLOOD-BANK
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3702833
• MDR Text Key: 4247159
• Report Number: 0001825034-2014-02133
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PBK070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 800-0505
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention