MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPSIII 60 W/ACDA JP; BIOLOGICS, INSTRUMENT

Catalog Number 800-1013

Device Problem Separation Problem (4043)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.Product not returned.

Event Description

It was reported the surgeon was trialing the gps iii.However, the blood was not separated properly and also the syringe did not work properly.There was no patient involvement as this did not occur during a procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was unable to be confirmed.Visual examination of the returned product identified no occlusions in the tube and that there is no damage to any of the ports.Based on the photos provided, the blood did separate.Device history record 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: GPSIII 60 W/ACDA JP
• Type of Device: BIOLOGICS, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8398390
• MDR Text Key: 138425740
• Report Number: 0001825034-2019-00996
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 800-1013
• Device Lot Number: 801924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1