MAUDE Adverse Event Report: BIOMET BIOLOGICS GPS III PLATELET CONCENTRATE SEPARATION KIT/SINGLE DISPOSABLE 30ML ACD-A; SUPPLIES, BLOOD BANK

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Customer has indicated that the product will not be returned [hospital retained product] 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 once the kit was opened for an orthobiologics procedure, the acd-a solution bottle was found to be cracked.A new bottle was available for use to complete the procedure.No patient consequences were reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed based on limited information received.Device history record (dhr) was reviewed and no discrepancies were found.No device or photos were received; therefore the visual inspection was not performed.Review of the complaint history determined that no further action is required.A definitive root cause could not be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Manufacturer Narrative

(b)(4).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

It was reported that once the kit was opened for an orthobiologics procedure, the acd-a solution bottle was found to be cracked.The procedure was not completed.No patient consequences were reported as a result of the malfunction.

• Brand Name: GPS III PLATELET CONCENTRATE SEPARATION KIT/SINGLE DISPOSABLE 30ML ACD-A
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6642990
• MDR Text Key: 77632595
• Report Number: 0001825034-2017-03968
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2017

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: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 800-1003A
• Device Lot Number: 601685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 09/20/2017; 09/21/2017
• Supplement Dates FDA Received: 09/20/2017; 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2016
• 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