MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL M; ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,MEDIUM, NEUTRAL

Model Number	15-2814/03
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Representative (b)(6) reported that (b)(6) had a tibial component that would not release one of the screws - it seemed stripped.It was the medial side screw.The other screw came out with no issue.Surgery time was not extended as the augment was then just cemented in place.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
Representative m.P.Reported that dr.(b)(6) had a tibial component that would not release one of the screws - it seemed stripped.It was the medial side screw.The other screw came out with no issue.Surgery time was not extended as the augment was then just cemented in place.[customer].

• Brand Name: ENDO MODEL M
• Common Device Name: ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,MEDIUM, NEUTRAL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18694249
• Report Number: 3004371426-2024-00020
• Device Sequence Number: 8509370
• Product Code: KRO
• UDI-Device Identifier: 04026575316298
• UDI-Public: 04026575316298
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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
• Device Model Number: 15-2814/03
• Device Catalogue Number: 15-2814/03
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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 Age: 57 YR
• Patient Sex: Male