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

Catalog Number 912082

Device Problem Difficult to Advance (2920)

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

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: jgrknt 1.0mm mini 3-0 ndls, cat#912082, lot#899730.Report source: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00148.

Event Description

It was reported the juggerknot mini¿s transparent sleeve cannot slide back during the implant insertion during a hand procedure.The transparent sleeve was stuck.Therefore, the implant could not be used.This occurred with two different implants.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Two juggerknot mini were returned for evaluation.Functional check was performed and were found to be conforming and the devices work as intended.Device history record was reviewed and no discrepancies were found.Review of the product determined that no failure was found as the product functions as intended.A summary of the investigation has been sent to the complainant.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: JUGGERKNOT 1.0MM MINI 3-0 NDLS
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9574310
• MDR Text Key: 204224433
• Report Number: 0001825034-2020-00147
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: K140908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 912082
• Device Lot Number: 615150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1