MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION SAFE GUIDING REAMER Ø11MM

Catalog Number	02.07.10.4048
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation performed by r&d project manager: during gmk revision surgery performed through crossover technique, the surgeon complained for inaccurate tibia e femur stem preparation due to a improper reamer guidance into the reamer sleeves.The technique is based on the final forcing of the stem direction after tibia and femur bone finishing.In this situation the final stem position is not centered to the femur/tibia intramedullary canal.During this surgery it could happened that during final stem reaming the reamer direction have been diverted and the final stem position was not alignet to the tibia and femur resection.After more that 12 years of using this technique, and thousands of cases, this is the first official complaint of this kind of trouble.Despite this, the need to introduce specific reamers and/or guiding bushes will be carefully evaluated.Other instrument involved: gmk-revision 02.07.10.4050 safe guiding reamer ø13mm lot.Unknown.
Event or Problem Description
When using the crossover instrumentation, it was noticed that the reamers in the sleeves do not have proper guidance as soon as they are inserted into the shaft and tend to deviate.This created problems when placing the trials and the final implants.The surgeon first used safe guiding reamer ø11mm, then safe guiding reamer ø13mm, anf inally safe guiding reamer ø16mm.The operation time was extended by about an hour and more anesthetic had to be administered.On the tibia, the tibia was initially not placed cleanly on the resection because the shaft was diverted.The femur was flexed and had no secure hold by the shaft.This had to be held in place for cementation, otherwise it would not have remained in the correct position.No defects can be noted on the reamers.The patient was very young and had hard bones.

• Brand Name: GMK-REVISION SAFE GUIDING REAMER Ø11MM
• Common Device Name: REAMER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20320103
• Report Number: 3005180920-2024-00772
• Device Sequence Number: 7782969
• Product Code: LXH
• UDI-Device Identifier: 07630040760119
• UDI-Public: 07630040760119
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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 Catalogue Number: 02.07.10.4048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male