MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG LINKSYMPHOKNEE; PATELLA SIZING TEMPLATE, STAINLESS STEEL

Model Number	881-509/00
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
For prof.(b)(6), the patella selected with the sizing template appeared too large.A remeasurement of the sizing template has obviously resulted in a reversed labeling on the sizing template.[customer].
Additional Manufacturer Narrative
As a corrective measure, a product inspection is initiated under recall r-2024-06.Furthermore a capa was initiated to determine further corrective and preventive action.This is the final supplemental report, the complaint is closed.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: PATELLA SIZING TEMPLATE, STAINLESS STEEL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19631399
• Report Number: 3004371426-2024-00050
• Device Sequence Number: 15240367
• Product Code: HWT
• UDI-Device Identifier: 04026575310203
• UDI-Public: 04026575310203
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Remedial Action: Inspection,Recall
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: 881-509/00
• Device Catalogue Number: 881-509/00
• Device Lot Number: C225066
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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