MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI ROD REDUCTION DEVICE; INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.75.10.0060
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 03 september 2019: lot 1853461: (b)(4) items manufactured and released on 05-feb-2019, (b)(4) items released on 28-feb-2019.No anomalies found related to the problem.To date, no other similar events have been reported.Visual inspection performed by medacta spine r&d project manager: based on the event description, it was assumed that rod reduction was a challenging manoeuver due to the high force necessary to position the rod in the poly-axial screw head.Actually, it is not uncommon that this event can occur when there is large rod reduction in combination with very adjacent screws positioning.In this case the manoeuver requires high force that might lead to potential risks for patient' health.For the reason of that, the choice to proceed with additional rod contouring might be more appropriate.From the side of instrument, the implant-instrument interface has been improved through the mr272-17, by increase the stiffness of the instrument as well as by reducing the tolerances, in order to obtain a more precise and efficient implant-instrument interface.During the visual inspection on the retrieved instrument was observed that the interface was a bit damaged and tolerances were not conforming anymore.It was assumed to be one of the potential root cause of not be able to perform reduction: slip-off from the poly-axial screw head during reduction.However, it was not possible to identify any potential implant interface damaging because of parts were not available for investigation.A potential implant-interface damaging might also affect the success of such a manoeuver.Additional devices involved in the complaint batch review performed on 03 september 2019: must mini 03.75.005 must mini polyaxial screw 3.5 x 20 full thread + nut (k171369) lot 1920271: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.(b)(4) devices of the same lot involved in this complaint.
Event or Problem Description
Spinal fixation performed at c2-t1.After the insertion of the rod, the surgeon tried to use the rod reduction device because the rods were not inserted completely into the pedicle screw heads at both side of c5.When the surgeon gripped the handle of the rod reduction device, the rod reduction device easily disengaged from the pedicle screw head.The surgeon was not able to insert the rod because the same event recurrented many times.The surgeon disengaged the rod and perform the rod bending again and finished the surgery without using the rod reduction device.Due to this event the surgery was prolonged about 30 minutes.Total surgery time was about 5 hours.

• Brand Name: MUST MINI ROD REDUCTION DEVICE
• Common Device Name: INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9128862
• Report Number: 3005180920-2019-00807
• Device Sequence Number: 2030642
• Product Code: LXH
• UDI-Device Identifier: 07630971208872
• UDI-Public: 07630971208872
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 03.75.10.0060
• Device Lot Number: 1853461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other