MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS-K HEAD REAMER Ø 8; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.20.10.100
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distal reamer detached from the long rigid shaft for reamers and remained stuck in the distal femur during amis-k femur preparation.The surgeon turning the reamer in counterclockwise direction (the instrument cut in clockwise direction).30 minutes of delay in the surgery to recover the reamer.
Additional Manufacturer Narrative
Batch review performed on 29 august 2023: lot 2052533: (b)(4) items manufactured and released on 14-jul-2020.No anomalies found related to the problem.To date, no other similar events have been reported during the period of review.Preliminary investigation performed by r&d project manager: the surgeon used the reamer in counterclockwise direction for reaming, that is an off-label use.Very likely the misuse of the instrument is the reason why the head reamer disconnected from the shaft and got stuck inside the canal of the femur.Visual inspcetion performed by r&d project manager: from a visual inspection both reamer head and shaft are damaged and it is impossible to match each other.This is due to the fact that the instruments have not been used correctly.The thread of 01.20.10.100 is fine since it is possible to thread a screw thread m6.Therefore the preliminary evaluation is confirmed, the event is due to the misuse of the instruments (off-label).Additional instrument involved: batch review performed on 29 august 2023 on amis-k 01.20.10.119 long rigid shaft for reamers lot.1955868 lot 1955868: (b)(4) items manufactured and released on 13-feb-2020.No anomalies found related to the problem.To date, no other similar events have been reported during the period of review.

• Brand Name: AMIS-K HEAD REAMER Ø 8
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• 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: 17648994
• Report Number: 3005180920-2023-00655
• Device Sequence Number: 7212803
• Product Code: LXH
• UDI-Device Identifier: 07630040758543
• UDI-Public: 07630040758543
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/30/2023

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: 01.20.10.100
• Device Lot Number: 2052533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• 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: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic