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.

Event Description

It was reported that expiry dates on implant stickers and outer packaging was not matching.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.Reported event was confirmed by review of the provided pictures.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required review of the provided picture determined that the manufacturing date, not the sterile expiration date, is printed on the patient labels.The expiration date on the outer label is correct.Root cause of the reported event was determined to be a labeling deficiency at the supplier.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: 6746341
• MDR Text Key: 81325651
• Report Number: 0001825034-2017-05091
• 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: 11/08/2017

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: 11/08/2017
• 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