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

Model Number	15-0028/07
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed that there was an issue with the screws packaged with the endo model fusion nail.The complainant stated that 2 lots of the fusion nail were opened and did not have pre-loaded screws in the trunnion.Each package only contained 4 "flat" secondary screws in a separate package.Lot 2545069 was opened first, then lot 2535246 was opened but they were the same - no pre-loaded screws, only 4 secondary screws.Lot 2535246 was implanted with no issue reported after using the secondary screws in the procedure.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.
Additional Manufacturer Narrative
The review of the device history record showed no deviations.This is the final supplemental report, the complaint is closed.
Event or Problem Description
We have been informed that there was an issue with the screws packaged with the endo model fusion nail.The complainant stated that 2 lots of the the fusion nail were opened and did not have pre-loaded screws in the trunnion.Each package only contained 4 "flat" secondary screws in a separate package.Lot 2545069 was opened first, then lot 2535246 was opened but they were the same - no pre-loaded screws, only 4 secondary screws.Lot 2535246 was implanted with no issue reported after using the secondary screws in the procedure.[customer].

• Brand Name: ENDO-MODEL FUSION NAIL
• Common Device Name: ENDO-MODEL KNEE FUSION NAIL SK, COUPLING COMPONENT, LEFT, UHMWPE, COCRMO 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: 24275945
• Report Number: 3004371426-2026-00006
• Device Sequence Number: 9862454
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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 Model Number: 15-0028/07
• Device Catalogue Number: 15-0028/07
• Device Lot Number: 2545069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown