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

Catalog Number	03.52.10.0406
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided: the agent stated that the surgeon kept grabbing the shaft of the driver while inserting the screw.It was the agent's opinion that the tip of the driver was not fully inserted into the screw and the surgeon was instructed to re-engage the driver and refrain from gripping the shaft while advancing the screw.Batch review performed on 12 april 2019: lot 1651130: (b)(4) items manufactured and released on 25-jul-2016.No anomalies found related to the problem.To date, three other similar events have been already reported on this lot.Visual inspection performed by r&d project manager: the tip of the screwdriver torx t20 of the ref.03.52.10.0406, lot 1651130 is broken.The lines of fracture are on one side of the screwdriver and there are signs on the opposite side of the shaft of the screwdriver.The type of breakage is compatible with a bending/torsion of the screwdriver, maneuver that has to be avoided.By the description of the event, it seems that the outer shaft of the screwdriver is not engaged on the tip of the driver.In this condition, the tip of the screwdriver is more sensible to the lateral bending force.The signs on the shaft on the opposite side of the lines of fracture confirm the failure mechanism mentioned above.The root cause of the breakage is probably the application of lateral bending on the screwdriver during the screw insertion.
Event or Problem Description
During the primary spine surgery and while inserting a pedicle screw into the right l-3 pedicle, an audible sound was heard and the screw could no longer be advanced.Upon removing the driver, it was discovered that the tip of the driver had broken off inside of the screw.Some fragments of the broken tip were recovered but a portion of the tip could not be retrieved.The surgeon removed the screw and inserted another screw without incident and there was minimal delay in the case.The surgery was completed successfully.

• Brand Name: MIS PEDICLE SCREW MUST PEDICLE SCREWDRIVER - MIS HYBRID
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8522862
• Report Number: 3005180920-2019-00278
• Device Sequence Number: 16773271
• Product Code: LXH
• UDI-Device Identifier: 07630971202542
• UDI-Public: 07630971202542
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 1651130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• 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