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

Model Number	7.0727
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SPINE SURGERY CUSTOM INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11770197
• Report Number: 3005180920-2021-00350
• Device Sequence Number: 3425206
• Product Code: PQC
• UDI-Device Identifier: 07630971255784
• UDI-Public: 07630971255784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR