MAUDE Adverse Event Report: MECTRON S.P.A. PIEZOSURGERY; MT1 -10, IINSERT FOR GENERAL BONE SURGERY

Model Number MT1-10

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer mectron s.P.A.Received the insert involved in the event.An investigation was carry out by the manufacturer: the insert returned mt1-10, lot.Number 18002205 was analysed by an external laboratory.The result of this analysis didn't reveal any critical problem on the structure of the insert.Moreover the design, production, in -process an final controls documents, related to the insert mt1-10, lot.Number 18002205, didn't show any anomaly.

Event Description

During the use in the maxillofacial surgery the insert mt1-10, lot.N.18002205, broke.No adverse event occurred to the patient.More information about this insert: eto sterilization batch n.(b)(4); expiration date : july/30/2023.

• Brand Name: PIEZOSURGERY
• Type of Device: MT1 -10, IINSERT FOR GENERAL BONE SURGERY
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15/a; /; carasco, genoa 16042 ; IT 16042
• Manufacturer Contact: giovanna romeo ; via loreto 15/a; /; carasco, genoa 16042 ; IT 16042
• MDR Report Key: 8353086
• MDR Text Key: 139069977
• Report Number: 3003933619-2018-00008
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Model Number: MT1-10
• Device Catalogue Number: 03600001
• Device Lot Number: 18002205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR