MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE S02 LEFT GUIDE; SPINE SURGERY CUSTOM INSTRUMENT

Model Number 7.0727

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 12-apr-2021: lot 04280s: (b)(4) items manufactured and released on 22-mar-2021.Expiration date: 2021-07-05.No anomalies found related to the problem.

Event Description

The position of the tube, which indicates the screw trajectory, was completely different in comparison with the planning.This event was discovered the day before the surgery and the surgery was postponed by a week.The event was noticed using the k-wire with the guide.

Manufacturer Narrative

Visual inspection performed by r&d manager: the actual position of the tube does not respect the planned trajectory of the screw.The operator did not perform the matching between the tube and the pyramid that indicates the screw trajectory.Also, during the second control, by an independent operator, the issue was not detected.Based on these findings, the root cause is determined to be a gap in the design process that is too dependent on manual operator actions for this critical aspect of screw positioning.

• Brand Name: MYSPINE S02 LEFT GUIDE
• Type of Device: SPINE SURGERY CUSTOM INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11770197
• MDR Text Key: 257542600
• Report Number: 3005180920-2021-00350
• Device Sequence Number: 1
• Product Code: PQC
• UDI-Device Identifier: 07630971255784
• UDI-Public: 07630971255784
• Combination Product (y/n): N
• PMA/PMN Number: K200792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

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: 07/05/2021
• Device Model Number: 7.0727
• Device Catalogue Number: 7.0727
• Device Lot Number: 04280S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR