MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL SCREW KIT 2 HUMERAL SCREWS; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) report source, foreign ¿ events occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent the nexel elbow procedure.During the procedure, the humeral screw would not insert into the humeral component.The surgeon used another screw to complete the operation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Screws are returned for evaluation.The screws did not show any physical damage.Functional check was performed using sample devices.The humeral screws seated as intended.Dhr was reviewed and no discrepancies were found.Review of complaint history determined that no further actions are required.Root cause was unable to be determined, as the reported event could not be substantiated.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: HUMERAL SCREW KIT 2 HUMERAL SCREWS
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6981038
• MDR Text Key: 91188212
• Report Number: 0001822565-2017-07449
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00840009000
• Device Lot Number: 63696785
• Other Device ID Number: (01) 00889024271449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• 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