MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPINE INSTRUMENTS; POLYAXIAL SCREWDRIVER SLIM

Model Number	03.51.10.0136
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 01-10-2025.Lot: 1410893aba: (b)(4) items manufactured and released on 11-08-2016 no anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Investigation performed by r&d department pedicle screwdriver broke on the torx t20 interface with the screw, with a 45° angle, sign of excessive torque applied.The broken tip of the screwdriver was found inside the screw.For the pedicle screwdriver, breakage can occur in case of high insertion torque, typically related to large diameter screws ([?] 7mm), long screws ([?] 60mm), and/or hard bone (e.G.Sacral bone, sclerotic bone).In this case: screw size: ø6x45, tapping: ø6 undersized, bone quality: normal, level: s1.The instrument set includes two screwdrivers and another screwdriver (ref 03.51.10.0140 or equivalent) 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 application in terms of strength and hardness.Breakage of the tip may have occurred due to high insertion torque resulting from the combined factors of screw diameter, 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 insertion of a 6x45mm screw in s1 the tip of the screwdriver broke inside the screw head.Surgeon used a tulip and a 35mm rod to extract the screw.Backup screw (6x45mm) and screwdriver were used to complete the surgery.30 minutes of delay reported over 2h30 of surgery time.Bone quality was reported to be normal.Standard tapping was performed, 6mm (green colored).

• Brand Name: SPINE INSTRUMENTS
• Common Device Name: POLYAXIAL SCREWDRIVER SLIM
• 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: 23424080
• Report Number: 3005180920-2025-01031
• Device Sequence Number: 12832301
• Product Code: LXH
• UDI-Device Identifier: 07630971201620
• UDI-Public: 07630971201620
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Report Date (Section B): 10/30/2025

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: 03.51.10.0136
• Device Lot Number: 1410893ABA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2016
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown