MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MIS PEDICLE SCREW MIS LATERAL FRAME; SURGICAL INSTRUMENT FOR SPINE

Catalog Number	03.52.10.0202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: lot 1852695: (b)(4) items manufactured and released on 12-sep-2018.No anomalies found related to the problem.To date, no similar event has been reported.Preliminary investigation performed by r&d spine manager: from the pictures enclosed in the complaint and based on the description of the event it's not possible to identify a root cause of the event.A deeper analysis can be performed during the visual inspection.
Event or Problem Description
During the fluoroscopy control, the medical staff discovered a metal part inside the patient, it was the posterior gear of the mis lateral frame.The broken part has been removed successfully and the surgery was completed.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the component 68.11.200 (metal gear cap) is dismounted by the frame.According to the drawing, the component is assembled on the gear 68.11.192 by interference.The cap has small scratches on the internal surface, probably due to the application of lateral force on the knob.The functionality of the cap is to cover the gear and improve the gear centering.The functionality of the frame is "guaranteed" even without the presence of the cap.

• Brand Name: MIS PEDICLE SCREW MIS LATERAL FRAME
• 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: 8564992
• Report Number: 3005180920-2019-00334
• Device Sequence Number: 2387365
• Product Code: LXH
• UDI-Device Identifier: 07630971203822
• UDI-Public: 07630971203822
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 06/12/2019

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: 03.52.10.0202
• Device Lot Number: 1852695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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
• Patient Age: 68 YR