MAUDE Adverse Event Report: BIOMET BIOLOGICS STANDARD GPS 6 PACK; SUPPLIES, BLOOD-BANK

Model Number N/A

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2016

Event Type  malfunction  

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.There are warnings in the package insert that state that this type of event can occur: under warnings and precautions, "do not use sterile components in this kit if package is opened or damaged.".

Event Description

During a prp injection procedure, a particle of unknown material fell out of the device when being prepared for use.Another device was used to complete the procedure without delay.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device was unable to confirm the reported complaint.A conclusive root cause of the event could not be determined.

• Brand Name: STANDARD GPS 6 PACK
• 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: 5726018
• MDR Text Key: 47434302
• Report Number: 0001825034-2016-02062
• 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: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 800-1006A
• Device Lot Number: 600380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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