MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP- GPS DUAL TIP MALABLE 20GAX4IN; SYRINGE, IRRIGATING (NON DENTAL)

Model Number N/A

Device Problems Expiration Date Error (2528); Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device product code- kyz.Customer has not indicated that the product will not 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.Product is not being returned.

Event Description

It was reported that expiration dates on implant stickers and outer packaging did not match.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as no patient injury occurred, and this issue is not likely to lead to a serious injury if the event were to reoccur.The initial report was forwarded in error and should be voided.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.

• Brand Name: SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP- GPS DUAL TIP MALABLE 20GAX4IN
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 6746339
• MDR Text Key: 81326136
• Report Number: 0001825034-2017-05092
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK940371
• 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
• Report Date: 11/09/2017

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: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 800-0202
• Device Lot Number: 170250
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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