MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTAC MECTA-C INSERTER EVO; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.29.10.1010
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 march 2019.Lot 1855110: (b)(4) items manufactured and released on 29-nov-2018 no anomalies found related to the problem.To date, no similar event has ever been reported on this lot.Additional instrument involved: mectac 03.29.10.1011 mecta-c inserter evo inner shaft, lot unknown.
Event or Problem Description
During the primary spine surgery and while attempting to insert the cage, the mecta-c evo inserter struck the surgeon in the eye when he pulled back on the inserter.During the instrument removal the implant was detached from the instrument and the instrument was in "lock" position.There was no any damage of the instrument.The cage wasn't deformed.This caused a 30 minute delay in the case and the surgery was completed successfully.

• Brand Name: MECTAC MECTA-C INSERTER EVO
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8394729
• Report Number: 3005180920-2019-00132
• Device Sequence Number: 2029950
• Product Code: LXH
• UDI-Device Identifier: 07630971217683
• UDI-Public: 07630971217683
• 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): 03/06/2019

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: 03.29.10.1010
• Device Lot Number: 1855110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/06/2019
• 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