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

Catalog Number	03.52.10.0406
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6)2023.Lot 2057424: 21 items manufactured and released on 22-apr-2022.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.Preliminary investigation performed by r&d project manager based on the picture received according to picture received, the 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 or equal to 7mm), long screws (more or equal to 60mm), and/or hard bone (e.G.Sacral bone, sclerotic bone).In such cases, bone tapping is recommended in the surgical technique.In this case, information about screw size, tapping performed, bone quality, and level are unknown surgery was completed with another screwdriver.The instrument set includes a second pedicle screwdriver and another "simple" 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.
Event or Problem Description
During surgery the tip of the must pedicle screwdriver broke.The surgery was delayed of 3 hours in order to remove the pedicle screw because the instrument tip was stuck in the tulip.
Additional Manufacturer Narrative
On 6th october 2023 we have received the item involved in the event.The item has been analyzed and it has been confermed what already communicated in the preliminary investigation.Visual inspection perfromed by r&d project manager (same as prelinimary investigation): according to picture received, the 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 or equal to 7mm), long screws (more or equal to 60mm), and/or hard bone (e.G.Sacral bone, sclerotic bone).In such cases, bone tapping is recommended in the surgical technique.In this case, information about screw size, tapping performed, bone quality, and level are unknown.Surgery was completed with another screwdriver.The instrument set includes a second pedicle screwdriver and another "simple" 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.

• Brand Name: MIS PEDICLE SCREW MUST PEDICLE SCREWDRIVER - MIS HYBRID
• Common Device Name: SPINE PEDICLE SCREW SCREWDRIVER
• 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: 17729257
• Report Number: 3005180920-2023-00710
• Device Sequence Number: 20443151
• Product Code: LXH
• UDI-Device Identifier: 07630971202542
• UDI-Public: 07630971202542
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/30/2023

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: 03.52.10.0406
• Device Lot Number: 2057424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic