MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL-M; ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,MEDIUM, NEUTRAL

Model Number 15-2814/03

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/22/2023

Event Type  Injury  

Event Description

During the surgery one screw came out, the second screwed.Surgery time was prolonged, because they used the screw extraction kit unnecessarily, in the end they only put one screw fastening and cement, as suggested in previous fsn and the implant was successfully completed.We are reporting the episode because in the fsn ref.R-2022-01, affected items should have been only those in production until may 2022, whereas this item was produced in february 2023.[customer].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.Note on exceeding the reporting deadline reporting deadline 23 december 2023 reporting date 24 january 2024 this initial report is delayed due to an it security-related incident from 18 december 2023.Due to the incident, we did not have access to our it systems and were temporarily unable to meet our obligation to report incidents on time.The process-relevant functions have been available again since 16 january 2024.Accordingly the reports will now be submitted retrospectively.

• Brand Name: ENDO-MODEL-M
• Type of Device: ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,MEDIUM, NEUTRAL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18571268
• MDR Text Key: 333607318
• Report Number: 3004371426-2024-00013
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575316298
• UDI-Public: 04026575316298
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 15-2814/03
• Device Catalogue Number: 15-2814/03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2023
• 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 Outcome(s): Required Intervention