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

Model Number	01.22.10.0109
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 march 2022: lot 1652320: (b)(4) items manufactured and released on 23-mar-2017.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.Additional devices involved: batch review performed on 31 march 2022.Stem: m-vizion 01.22.105 distal stem ø16mm l 140mm straight (k170690) lot 2010764: (b)(4) items manufactured and released on 16-jun-2021.Expiration date: 2026-jun-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Stem: m-vizion 01.22.408 proximal body ø20mm l 50mm lat with holes (k201471) lot 2010781: (b)(4) items manufactured and released on 02-sep-2021.Expiration date: 2026-aug-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.M-vizion 01.22.10.0110 disassembly tool lot 1853910: (b)(4) items manufactured and released on 11-jul-2019.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.M-vizion 01.22.10.0151 proximal body handle lot 2055070: (b)(4) items manufactured and released on 06-apr-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.
Event or Problem Description
During the revision hip surgery, during the implant removal attempt, the surgeon was not able to thread the proximal body handle (01.22.10.0151 - 2055070) onto the implanted proximal body.He then switched to the second handle in the tray (01.22.10.0151 - 2053402) and successfully threaded the handle onto the proximal body.The disassembly tool (01.22.10.0110 - 1853910) would then not thread into the handle.Since the disassembly tool was not usable, the surgeon applied vice grips to the handle (2053402) that was attached to the proximal body and attempted to knock the body loose from the stem.After failing to disengage, the surgeon switched to the first handle (2055070) and was able to thread it into the proximal body.At this point, the disassembly tool was threaded into the handle and used as designed with the disassembly rod to attempt to disengage the body from the stem, which failed.The disassembly rod failed to disengage the morse taper between the distal stem and the body.The surgeon had to do an extended trochanteric osteotomy in order to remove the m-vision implants from the femur.There was a 1-hour delay and the surgery was completed successfully.A consignment set was utilized.
Additional Manufacturer Narrative
On 19.April.2022 we have received the items involved in the complaint.Visual inspection performed by r&d project manager: the disassembly rod analyzed showed visible deformation, probably due to a compression load higher than expected during the step of dissassemblling the proximal body from the distal stem.The dimensions, material and hardness of the disassembly rod have been inspected and resulted conforming to specification.The root cause could be that the force required to detach the proximal body from the distal stem was higher than usual due cold welding of the modular junction, probably as result of a particular combination of stem/proximal body modular junction dimensions (according to manufacturing tolerances).Proximal body and distal stem are not availble for inspection so it is not possible to confirm above statement.

• Brand Name: M-VIZION DISASSEMBLY ROD
• Common Device Name: HIP SURGICAL INSTRUMENT
• 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: 14159205
• Report Number: 3005180920-2022-00270
• Device Sequence Number: 14692795
• Product Code: LXH
• UDI-Device Identifier: 07630040738958
• UDI-Public: 07630040738958
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 05/17/2022

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: 01.22.10.0109
• Device Catalogue Number: 01.22.10.0109
• Device Lot Number: 1652320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown