MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW LOCKING TOWER ENH 2019; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.51.10.0583
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 may 2021: lot 2052849: (b)(4) items manufactured and released on 13-jan-2021.No anomalies found related to the problem.To date, no other similar events have been reported.Visual inspection performed by r&d project manager: after the end of the surgery, it was noticed that one of the plates of ref 03.51.10.0583, lot 2052849, detached from the instrument.The parts are not conforming to the drawing since the welding of the plate on the inner tube is not complete.The root cause of this failure might be related to a welding problem.During the visual inspection, it was noticed that the remaining plate is not completely welded to the inner tube.In particular, it looked like only half of the plate is welded, the remaining part is not.In addition, as it is possible to see from the microscope images of the inner tube, the lateral zone of the tube seems damaged.This might be related to the excessive power of the laser beam used for the welding.Clinical evaluation performed by medical affairs director: a small metal particle, few mm in dimension, is torn away from an instrument during spinal scoliosis correction.It is detected immediately after surgery through xray examination.The sutured wound is reopened and the small piece extracted.There is no clnical cause for this event.No clinical consequence should be expected as the particle has been promptly removed; the only remaining clinical damage is the reopening of the wound.
Event or Problem Description
After surgery it was noticed that the instrument tip plate was broken and left in the patient.The surgeon removed the same day the instrument part from the patient.

• Brand Name: PEDICLE SCREW LOCKING TOWER ENH 2019
• 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: 11862215
• Report Number: 3005180920-2021-00405
• Device Sequence Number: 4414715
• Product Code: LXH
• UDI-Device Identifier: 07630971256538
• UDI-Public: 07630971256538
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/21/2021

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: 03.51.10.0583
• Device Lot Number: 2052849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/21/2021
• 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: Required Intervention