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 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

Upon reassessment of the reported event, it was determined to be not reportable as this malfunction has not previously caused a serious injury.

• 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: 6746340
• MDR Text Key: 81324200
• Report Number: 0001825034-2017-05090
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• 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?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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