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

Model Number N/A

Device Problem Difficult to Advance (2920)

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

Event Date 01/13/2020

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 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.

Manufacturer Narrative

Visual evaluation of the returned product identified no visible damages to both the suture and step drill.The sleeve was not retracted all the way to the handle and some scuffing was noted.Function check was conforming and the device works 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.

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
• MDR Report Key: 9637238
• MDR Text Key: 199990211
• Report Number: 0001825034-2020-00272
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00880304523418
• UDI-Public: (01)00880304523418
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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: 912082
• Device Lot Number: 353060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1