MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS CUP IMPACTOR TERMINAL-M10; SURGICAL INSTRUMENT FOR HIP SURGERY

Model Number	01.15.10.0263
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation performed by r&d project manager: looking at the image attached to the complaint it is visible that the terminal is blocked inside the cup.It is not possible to determine the root casue even if it is possible that the instrument balinit coating is scratched and this caused the cold welding with the cup.Batch review performed on 17 june 2022: lot 2053947: (b)(4) items manufactured and released on 28-july-2021.No anomalies found related to the problem.To date, no other similar events have been reported during the period of review.Additional implant involved: batch review performed on 01 june 2022 on cup versafitcup cc trio 01.26.45.0054 acetabular shell cc trio ø 54 (k103352) lot.2112747: (b)(4) items manufactured and released on 14-dec-2021.Expiration date: 2026-11-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Terminal for cup impactor and versafitcup cc trio cold welding during the surgery, a back up shell of the same size was open and used without success because the press fit in the bone wasn't good.Due to this an additional acetabular bone reaming was necessary and a new cup size 56 was finally implanted with success.1,30h delay in the surgery.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.During the analysis it is evaluated that the balinit coating on the instrument body is scratched and some sings are present.Some coating sings are present also on the cup body.The scratched of the balinit coating should be the cause of the reported cold welding with the cup.

• Brand Name: AMIS CUP IMPACTOR TERMINAL-M10
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14787360
• Report Number: 3005180920-2022-00481
• Device Sequence Number: 4677616
• Product Code: LXH
• UDI-Device Identifier: 07630040736015
• UDI-Public: 07630040736015
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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 Model Number: 01.15.10.0263
• Device Catalogue Number: 01.15.10.0263
• Device Lot Number: 2053947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown