MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE 7.0* MYSPINE DRILL PILOT GUIDE

Catalog Number 7.0*

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 10-jun-2022.Lot 07045s: (b)(4) items manufactured and released on 03-may-2022.No anomalies found related to the problem.Analysis performed by mysolution department: our analysis of the myspine process found no deviations from the standard procedures.Each step has been performed correctly.Regarding the myspine process, the interference between guides and ribs is verified twice; during the guides design and the guides check too.In the planning phase, we have not the ribs inside the spine view yet (but we will have them in the next revision of the software that will be online soon).On 30.05.2022 it was verbally confirmed that the guides fitted correctly also with the ribs.

Event Description

The all lowprofile myspine guides did not fit correctly with the patient's anatomy.The screws were inserted by using the navigation system and the surgery was completed successfully.14 hours of surgery, 2 hours of delay.

Manufacturer Narrative

Visual inspection performed by medacta spine r&d project manager: we have just analysed the fitting of all the guides received from japan.I can confirm you that our analysis found no issues from the standard fitting procedures, everything is conform without any kind of problem or doubt on the guides docking position.Each guide has been checked correctly resulting in a unique stable posistion.

Event Description

The all lowprofile myspine guides did not fit correctly with the patient's anatomy.The screws were inserted by using the navigation system and the surgery was completed successfully.14 hours of surgery, 2 hours of delay.

• Type of Device: SPINE DRILL PILOT GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14698707
• MDR Text Key: 294122706
• Report Number: 3005180920-2022-00453
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7.0*
• Device Lot Number: 07045S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian