MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPINE INSTRUMENTS; MUST PEDICLE SCREWDRIVER - MIS HYBRID

Model Number	03.52.10.0406
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 october 2025: lot 1952060: (b)(4) items manufactured and released on 09-dec-2019.No anomalies found related to the problem.To date, 4 similar events have been reported on the same lot during the period of review.Pedicle screw 03.52.323 enh.Cann.Pedicle screw 6x40mm + nut (1x) sterile (k141988) lot 2328427: (b)(4) items manufactured and released on 29-nov-2023.Expiration date: 2028-nov-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Visual inspection performed by medacta spine r&d project manager: pedicle screwdriver broke on the torx t20 interface with the screw, with a 45° angle, sign of excessive torque applied.For the pedicle screwdriver, breakage can occur in case of high insertion torque, typically related to large diameter screws (more than 7mm), long screws (more than 60mm), and/or hard bone (e.G.Sacral bone, sclerotic bone).In this case: screw size: ø6x40; tapping: yes; bone quality: good; level: l4-l5.The instrument set includes two screwdrivers and another screwdriver to complete the surgery in case of breakage.The strength of the tip of the screwdriver is determined by the dimension of the interface (hexalobe t20) and the material (aisi 420 mod), which are comparable to predicate devices.Geometrical features are driven by the implant design and are equivalent to similar products in the market.The material is among the strongest for such applications in terms of strength and hardness.The screw present the torx with sign of deformation, probably caused by the breakage of the screwdriver.Conclusions: breakage of the tips may have occurred due to high insertion torque resulting from the combined factors of screw diameter, hard/sclerotic bone condition, and the specific conditions of the screw hole preparation, in combination with the inherent mechanical limits of the devices involved.The device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
During spinal mis surgery, the tip of a screwdriver broke while implanting the third pedicle screw (surgical tecnique followed, awl, wire and tap used), causing slight damage to the screw tulip and making the instrument unusable.The surgery was not affected, as a spare screwdriver was available, and no harm occurred to the patient.The operated levels were l4-l5.The patient's bone quality was good, with no signs of osteoporosis or abnormal density.A new screw (size unknown) was opened and used because the damaged screw showed minor denting, even though no fragment remained attached to the implant.The surgeon performed a mini-open approach (cut extension), used a pedicle awl and pedicle probe lumbar, to position the new screw.No part of the instrument remained in the patient.

• Brand Name: SPINE INSTRUMENTS
• Common Device Name: MUST PEDICLE SCREWDRIVER - MIS HYBRID
• 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: 23591140
• Report Number: 3005180920-2025-01108
• Device Sequence Number: 21299355
• Product Code: LXH
• UDI-Device Identifier: 07630971202542
• UDI-Public: 07630971202542
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 03.52.10.0406
• Device Lot Number: 1952060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female