MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS 3 MINI TUBE ONLY; SUPPLIES, BLOOD-BANK

Model Number N/A

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has not indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a procedure on the patient's medial collateral tendon, the gps kit was used, however, platelet rich plasma (prp) did not separate as it was meant to.No additional information is available at this time.

Manufacturer Narrative

Reported event was unable to be confirmed as no device or photos were received and the condition of the component is unknown dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information received.

Event Description

Received lot number of device.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: GPS 3 MINI TUBE ONLY
• Type of Device: SUPPLIES, BLOOD-BANK
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8105558
• MDR Text Key: 128397149
• Report Number: 0001825034-2018-10650
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• PMA/PMN Number: BK070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 800-0745
• Device Lot Number: 600981
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1