MAUDE Adverse Event Report: MECTRON S.P.A. PIEZOSURGERY; PIEZOSURGERY MEDICAL INSERT TIP

Model Number MT1S-10

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/01/2018

Event Type  Injury  

Event Description

During a strip craniectomy for the release of the sagittal suture, the medical insert tip broke while in use.It was reported that the patient required re-opening of the incision and additional anesthesia to remove the object.The object was removed without any reported complication.No further information was received regarding the patient status.The event was reported to have occurred in (b)(6) 2018, but the exact date was not provided.

• Brand Name: PIEZOSURGERY
• Type of Device: PIEZOSURGERY MEDICAL INSERT TIP
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15a; carasco, ge 16042 ; IT 16042
• MDR Report Key: 8164921
• MDR Text Key: 130357080
• Report Number: 3005282635-2018-00002
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2018,11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO