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

Catalog Number 912082

Device Problems Fracture (1260); Component Misassembled (4004)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the surgery when the packaging was opened for the product, the product was fractured and misassembled in the packaging.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the item and lot number on the packaging label matches the complaint as it is not etched on the part.Product was returned in its original packaging but opened.The device looked to be disassembled, sutures and sleeve were not on tip as the tip was fractured and the fractured piece was missing & not returned.The luer cap was not threaded on the handle and the foam pad with the needle was not in handle.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: JUGGERKNOT MINI
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19086082
• MDR Text Key: 340120064
• Report Number: 0001825034-2024-00993
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00880304523418
• UDI-Public: (01)00880304523418(17)280616(10)0002529527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0002529527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 06/26/2024
• Supplement Dates FDA Received: 06/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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