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

Model Number	15-2814/02
Medical Device Problem Codes	Separation Failure (2547); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) was using an endo model m tibial component (220808/2706) and one of the blind screws for attaching the augment could not be removed and the head got stripped.A second tibial component was opened and a new screwdriver was used but this also had one screw that was locked and could not be removed, leading to this screw head becoming stripped as well.The augment used was then cemented in place and the second tibial component was implanted.Surgery time was extended approximately 15 minutes.Note: the second tibial component is within the scope of recall r-2022-01, but the first tibial component which was opened, and displayed the same issue as the tibial components within the scope of that recall, was manufactured in dec 2022, and therefore is outside the scope of that recall.[customer].
Event or Problem Description
Dr.(b)(6) was using an endo model m tibial component (b)(6) and one of the blind screws for attaching the augment could not be removed and the head got stripped.A second tibial component was opened and a new screwdriver was used but this also had one screw that was locked and could not be removed, leading to this screw head becoming stripped as well.The augment used was then cemented in place and the second tibial component was implanted.Surgery time was extended approximately 15 minutes.Note: the second tibial component is within the scope of recall r-2022-01, but the first tibial component which was opened, and displayed the same issue as the tibial components within the scope of that recall, was manufactured in dec 2022, and therefore is outside the scope of that recall.[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.

• Brand Name: ENDO MODEL M
• Common Device Name: ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,SMALL, NEUTRAL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18694248
• Report Number: 3004371426-2024-00019
• Device Sequence Number: 12889039
• Product Code: HRY
• UDI-Device Identifier: 04026575316281
• UDI-Public: 04026575316281
• 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): 01/24/2024

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 Expiration Date: 07/31/2026
• Device Model Number: 15-2814/02
• Device Catalogue Number: 15-2814/02
• 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: 01/24/2024
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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: 53 YR
• Patient Sex: Female