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 Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the surgery one screw came out, the second screwed.Surgery time was prolonged, because they used the screw extraction kit unnecessarily, in the end they only put one screw fastening and cement, as suggested in previous fsn and the implant was successfully completed.We are reporting the episode because in the fsn ref.R-2022-01, affected items should have been only those in production until may 2022, whereas this item was produced in february 2023.[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.Note on exceeding the reporting deadline reporting deadline 23 december 2023 reporting date 24 january 2024 this initial report is delayed due to an it security-related incident from 18 december 2023.Due to the incident, we did not have access to our it systems and were temporarily unable to meet our obligation to report incidents on time.The process-relevant functions have been available again since 16 january 2024.Accordingly the reports will now be submitted retrospectively.
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
During the surgery one screw came out, the second screwed.Surgery time was prolonged, because they used the screw extraction kit unnecessarily, in the end they only put one screw fastening and cement, as suggested in previous fsn and the implant was successfully completed.We are reporting the episode because in the fsn ref.(b)(4), affected items should have been only those in production until (b)(6) 2022, whereas this item was produced in (b)(6) 2023.[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: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18571268
• Report Number: 3004371426-2024-00013
• Device Sequence Number: 7076834
• Product Code: KRO
• UDI-Device Identifier: 04026575316298
• UDI-Public: 04026575316298
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown