MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION INSERTER ROD; HIP SURGICAL INSTRUMENT

Catalog Number	01.22.10.0143
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 3 may 2024 lot 2055643: (b)(4) items manufactured and released on 15-apr-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Visual inspection performed by r&d project manager the inserter rod is broken at on side, the side that is supposed to be screwed to the distal stem.The threaded rod is also broken in the same way, at the end of the threaded portion, on one extremity.The cause of the breakage was probably the excessive force applied to the instruments during the extraction phase of the distal stem.The excessive extraction force was needed due to the fact that the surgeon impacted hard the stem down into the femur trying to reach a certain position without success, so then he decided to remove it but it was very difficult (the bone was sclerotic).Clinical evaluation performed by medical affairs department during index surgery the distal stem ø12mm l 180mm did not reach expected position due to sclerotic bone.The surgeon tried to remove the distal stem to ream further but the stem was too strongly fixed into the bone and for this reason the extraction devices broke and it was not possible to remove the stem.Therefore, the operation was completed with a leg lengthening of 6mm.Trial stem was not used.Additional involved devices.Batch review performed on 3 may 2024 on stem: m-vizion 01.22.131 distal stem ø12mm l 180mm straight (k191816) lot.2208012.Lot 2208012: (b)(4) items manufactured and released on 23-sep-2022.Expiration date: 2027-aug-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 3 may 2024 on m-vizion 01.22.10.0141 threaded rod lot.2055642 lot 2055642: (b)(4) items manufactured and released on 13-apr-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.
Event or Problem Description
The distal stem ø12mm l 180mm was not placed deep enough due to insufficient reaming.When trying to remove the distal stem to ream further, the extraction devices broke and it was not possible to remove the stem.A 40mm proximal stem and an xs head from competitor have been implanted.The operation was completed with a leg lengthening of 6mm.The patient bone was very sclerotic.Trial stem not used.

• Brand Name: M-VIZION INSERTER ROD
• Common Device Name: HIP SURGICAL INSTRUMENT
• 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: 19403911
• Report Number: 3005180920-2024-00358
• Device Sequence Number: 6955919
• Product Code: LXH
• UDI-Device Identifier: 07630040739221
• UDI-Public: 07630040739221
• 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): 05/28/2024

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: 01.22.10.0143
• Device Lot Number: 2055643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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