MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL KNEE FUSION NAIL SK; ENDO-MODEL FUSION NAIL, MODULAR

Model Number	15-0028/07
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the device history has been performed.No deviations were recognizable in the production documents.The complaint was originally received on 2-jul-2024.Based on the information available at that time, the case was classified as non-reportable.Based on new information brought to our attention on 16-oct-2025, the complaint was reevaluated and classified as reportable.The case is therefore being reported retrospectively.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Reported by customer on (b)(6) 2024, that a fusion was being implanted and found that one screw in the trunnion on the femoral component was in backwards.There was no patient harm or procedure delay as the screw was backed out and used and the procedure continued successfully.

• Brand Name: ENDO-MODEL KNEE FUSION NAIL SK
• Common Device Name: ENDO-MODEL FUSION NAIL, MODULAR
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 23448476
• Report Number: 3004371426-2025-00054
• Device Sequence Number: 8907766
• Product Code: KRO
• UDI-Device Identifier: 04026575175215
• UDI-Public: 04026575175215
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 15-0028/07
• Device Catalogue Number: 15-0028/07
• Device Lot Number: 2416289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Unknown