MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; PATELLA CLAMP

Model Number	445-904/00
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patella clamp arm broke and came apart during a procedure and the clip that holds the round plastic section on the arm was left in the wound.[customer].
Additional Manufacturer Narrative
The lot number was not provided and the manufacturing records could not be reviewed.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Notifed by representative (b)(6) that a patella clamp arm broke and came apart during a procedure and the clip that holds the round plastic section on the arm was left in the wound.It went unnoticed during the procedure but was shown on a post-op x-ray.They were in the process of cementing the patella when the round plastic part popped out.Lot code is unknown as the clamp arm was discarded.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: PATELLA CLAMP
• 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: 23024855
• Report Number: 3004371426-2025-00044
• Device Sequence Number: 9454734
• Product Code: HTX
• UDI-Device Identifier: 04026575184378
• UDI-Public: 04026575184378
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/09/2025

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: 445-904/00
• Device Catalogue Number: 445-904/00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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