MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL KNEE SYSTEM - INSTRUMENTS; SCREWDRIVER FOR CONE ADAPTERHXX

Model Number	151-131/00
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified late on (b)(6) 2026, that a surgery was going to be performed but an instrument in the cck tray had discoloration on it that looked like blood or rust.The surgery was cancelled and performed on (b)(6) 2026 instead, with the instrument removed out of the tray.The patient was already under anesthesia when the instrument was noticed so the surgery was cancelled and rescheduled for the next day.

• Brand Name: ENDO-MODEL KNEE SYSTEM - INSTRUMENTS
• Common Device Name: SCREWDRIVER FOR CONE ADAPTERHXX
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24886721
• Report Number: 3006721341-2026-00009
• Device Sequence Number: 13224601
• Product Code: HXX
• UDI-Device Identifier: 04026575302925
• UDI-Public: 04026575302925
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026
• Report Date (Section F): 03/20/2026

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: 151-131/00
• Device Catalogue Number: 151-131/00
• Device Lot Number: C232029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female