MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW DRIVER SLIM - SOLID; SPINE DRIVER

Catalog Number	03.51.10.1148
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 july 2024 lot 1657626: (b)(4) items manufactured and released on 24-may-2017.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.Clinical evaluation performed by medical affair director.During the implantation of an s1 screw, the tip of the screwdriver broke, remaining inside the screw head and preventing the surgeon from retrieving it.The available x-rays do not reveal the fragment.Although the instrument is made of medical-grade stainless steel, it does not belong to the series approved for long term implantation.Based on the report, the fragment remained not in direct contact with patient tissues (it is lodged between the screw head and the rod).However, we cannot guarantee the absence of interactions between the fragment and the mentioned implants.Although unlikely, we cannot be certain if this could lead to secondary clinical repercussions.Visual inspection performed by 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 (>= 7mm), long screws (>= 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 tapping and bone quality are unknown.It is possible that the combination between big screw diameter and level created the conditions for the failure.The instrument set includes two screwdrivers and another "simple" screwdriver (ref 03.51.10.0140 or equivalent) with solid tip to complete the surgery in case of breakage.
Event or Problem Description
During the insertion of the pedicle screw 9x40mm at right side of s1, the tip of the screwdriver broke.The surgeon was not able to retrieve the broken tip from the pedicle screw head, so the broken tip was remained in the patient body, and finished the surgery.

• Brand Name: PEDICLE SCREW DRIVER SLIM - SOLID
• Common Device Name: SPINE DRIVER
• 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: 19836978
• Report Number: 3005180920-2024-00559
• Device Sequence Number: 6768688
• Product Code: LXH
• UDI-Device Identifier: 07630971209268
• UDI-Public: 07630971209268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 03.51.10.1148
• Device Lot Number: 1657626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2017
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian