MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULATED; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.51.10.0222
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 10 february 2020: lot 1952049: (b)(4) items manufactured and released on 07-aug-2019.No anomalies found related to the problem.To date, no other similar events have been reported.Preliminary investigation performed by (b)(4) project manager: the screw head of the screw inserted in l5 was stuck at an angle that the plain screwdriver couldn't engage; the surgeon was able to engage the cannulated screwdriver (ref.03.51.10.0222), whose torx tip broke during the screw removal.Looking at the provided images, it is evident that even the initial portion of the screwdriver threaded connection is damaged.Therefore, it is possible that, due to the critical screw head angulation, the screwdriver was not properly aligned and engaged: only the initial portion of the thread was connected and consequently the torx tip was not fully inside the screw recess.For this reason, the removal torque was transmitted only by a small part of the screwdriver tip that consequently broke.The tip material and geometry is proven to withstand up to 9nm torque, which is a significant force for a pedicle screw insertion/removal.The strength of the tip of the screwdriver is driven by the dimensions (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 materials for such application in terms of strength and hardness.
Event or Problem Description
During the primary spine surgery, when the surgeon placed the left l5 screw, the surgeon decided that the disc space was so collapsed that he needed to remove it.The screw head locked and stuck an angle that the plain screwdriver couldn't engage.The surgeon then tried the cannulated driver that screws on, upon trying to turn out, the screw the tip of the cannulated screwdriver broke off inside the screw.The surgeon then attached a cut piece of rod and tightened it to "helicopter" the screw out with vice grips.The agent had extra screwdrivers in the set and the surgeon was able to use them.No fragments fell into the patient.This came from a loaner set.There was an hour long delay in the case and additional anesthesia was administered and re-dosing of antibiotics.The surgery was completed successfully.

• Brand Name: PEDICLE SCREW POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULATED
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9768913
• Report Number: 3005180920-2020-00107
• Device Sequence Number: 18963981
• Product Code: LXH
• UDI-Device Identifier: 07630971230767
• UDI-Public: 07630971230767
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 03.51.10.0222
• Device Lot Number: 1952049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/28/2020
• 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