MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL KNEE SYSTEM; HEX SCREWDRIVER, STAINLESS STEEL, L= 175 MM, ØSW 2.0 MM

Model Number	64-1181/06
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Notified by representative (b)(6) that during a case, the surgeon was tightening the screw and the tip broke off in the screw head.The surgeon could not get the tip out of the screw.There was no delay because of the break.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Additional Manufacturer Narrative
The review of the device history 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
Notified by representative (b)(6) that during a case, the surgeon was tightening the screw and the tip broke off in the screw head.The surgeon could not get the tip out of the screw.There was no delay because of the break.Customer.

• Brand Name: ENDO-MODEL KNEE SYSTEM
• Common Device Name: HEX SCREWDRIVER, STAINLESS STEEL, L= 175 MM, ØSW 2.0 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 22584856
• Report Number: 3004371426-2025-00038
• Device Sequence Number: 15773597
• Product Code: HXX
• UDI-Device Identifier: 04026575113750
• UDI-Public: 04026575113750
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 06/27/2025

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: 64-1181/06
• Device Catalogue Number: 64-1181/06
• Device Lot Number: C312094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown