MAUDE Adverse Event Report: PIEZOSURGERY; MT1S - 10, INSERT FOR GENERAL BONE SURGERY

Model Number MT1S-10

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturer mectron (b)(4) didn't receive the insert involved in the event.However the production, in-process and final controls documents, related to the insert mt1s -10, lot n.18000236, didn't show any anomaly.

Event Description

During the use in a strip craniectomy, for release of sagittal suture, the insert mt1s-10 broke.This required an additional procedure to remove the fragment of the insert.Device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: PIEZOSURGERY
• Type of Device: MT1S - 10, INSERT FOR GENERAL BONE SURGERY
• Manufacturer Contact: giovanna romeo ; via loreto, 15/a; /; carasco, genoa 16042 ; IT 16042
• MDR Report Key: 8350057
• MDR Text Key: 136619096
• Report Number: 3003933619-2018-00005
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: MT1S-10
• Device Catalogue Number: 03600007
• Device Lot Number: 18000236
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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: 3 MO