MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTENER, FIXATION

Catalog Number 110024773

Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign- denmark.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.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

It was reported that the juggerstitch device did not release the implant properly and the black trigger was very resistant.Another device was used to complete the procedure.No adverse event has been reported as a result of the malfunction.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The reported event has been made not reportable.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The reported event has been made not reportable.

• Brand Name: JUGGERSTITCH CURVED IMPLANT
• Type of Device: FASTENER, FIXATION
• 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: 18381030
• MDR Text Key: 331194479
• Report Number: 0001825034-2023-03001
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304690073
• UDI-Public: (01)00880304690073(17)280605(10)66110909
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K150424
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110024773
• Device Lot Number: 66110909
• 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: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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
• Patient Sex: Male