MAUDE Adverse Event Report: BIOMET BIOLOGICS GPS III SINGLE KIT W/30ML ACDA; SUPPLIES, BLOOD-BANK

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 01/13/2015

Event Type  Injury  

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.

Event Description

During a shoulder arthroscopy procedure, an unknown event occurred; it is indicated the blood platelet separation kit was involved.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to correct and relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "damage to blood vessels, hematoma, delayed wound healing and/or infection." review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.

Event Description

During a shoulder arthroscopy procedure, a blood platelet separation kit was used.The patient subsequently developed an infection.No further information has been provided.

• Brand Name: GPS III SINGLE KIT W/30ML ACDA
• Type of Device: SUPPLIES, BLOOD-BANK
• Manufacturer (Section D): BIOMET BIOLOGICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5939349
• MDR Text Key: 54311910
• Report Number: 0001825034-2016-03569
• 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: user facility
• Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 800-1003A
• Device Lot Number: 402274
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2016-008R
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other