MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENTHINGE VERSION,SMALL

Model Number	16-2841/02
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the histrory record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report.The complaint is closed.
Event or Problem Description
There is a foreign object in the socket head of the screw that prevents the screw from being used.[customer].

• Brand Name: ENDO-MODEL SL
• Common Device Name: CONNECTION COMPONENTHINGE VERSION,SMALL
• 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: 22882614
• Report Number: 3004371426-2025-00040
• Device Sequence Number: 21048113
• Product Code: KRO
• UDI-Device Identifier: 04026575359264
• UDI-Public: 04026575359264
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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 Model Number: 16-2841/02
• Device Catalogue Number: 16-2841/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown