MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; FASTNER, FIXATION

Model Number 912082

Device Problem Misassembled (1398)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign: (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 report will be submitted.

Event Description

It was reported that the sleeve on the instrument was incorrectly assembled.The product could not be used for surgery.Another product was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the position of the sleeve was not depressed all the way the handle.The suture line with anchor has been detached from the implant body.The surgical needles were also detached from the implant body.The step drill was not returned.Part and lot cannot be confirmed as they are not etched in the part.Function test of the clear sleeve found the product to function as intended.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to use error.As returned, the position of the sleeve was not depressed all the way to the handle, indicating the anchor was not deployed at the right depth, which would lead to anchor pullout.Per the juggerknot mini surgical technique, the user is instructed to "advance the inserter until the clear juggerknot guide sleeve has retracted to the handle completely to ensure the anchor has reached full depth".A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.This event will be considered as not reportable as the product was found to be properly functioning and no longer falls under a reportable malfunction.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

No further event information available at the time of this report.

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: FASTNER, FIXATION
• 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: 14142859
• MDR Text Key: 289528857
• Report Number: 0001825034-2022-00934
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00880304523418
• UDI-Public: (01)00880304523418(17)261106(10)0002399659
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 912082
• Device Catalogue Number: 912082
• Device Lot Number: 0002399659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose