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 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that during a finger tendon repair procedure, the juggerknot mini¿s transparent sleeve was stuck during the insertion process.Therefore, the juggerknot suture cannot be deployed in the bone.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d11, g4, g7, h1, h2, h3, h6, h10 visual evaluation of the returned product identified the clear sleeve was fully deployed upon receipt.The drill bit was not returned.One side of the inserter tip was fractured.The 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 the product functions as intended for sleeve jammed issue.However, a definitive root cause for fracture cannot be identified.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: 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: 9574649
• MDR Text Key: 204241008
• Report Number: 0001825034-2020-00153
• 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: 06/04/2020

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: 353060
• 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: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 77