MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE UNILATERAL LEFT GUIDE S01; SPINE SCREW PLACEMENT GUIDE

Catalog Number	7.1027
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 august 2024 lot 13813s: (b)(4) items manufactured and released on 04-jul-2024.Expiration date: 2024-dec-17.No anomalies found related to the problem.Other products involved in the event: myspine 7.1057 myspine unilateral right guide s01 (k231483) lot.13813s.Myspine 7.0726 myspine-mc drill guide s01 (k173472) lot.13813s.Myspine 7.1055 myspine unilateral right guide l05 (k231483) lot.13813s.Myspine 7.1025 myspine unilateral left guide (k231483) l05 lot.13813s.Myspine 7.0555 myspine lp drill pilot guide l05 (k153273) lot.13813s.Note: the complaint was reported late (over 30 days) due to human error.Today, august 21, 2024, the error was noticed and the complaint was reported.
Event or Problem Description
The trajectory obtained using myspine unilateral guides at s01 and l5 was incorrect.He began at s1 and according to him he did a thorough soft tissue dissection and was satisfied that the in situ fit was just as solid as the fit on the vertebral model.He introduced the drill and took a fluoro shot, indicating the trajectory was incorrect.He spent almost 30-40 minutes trying to get the guide positioned correctly but was convinced that the guide was probably printed incorrectly.He then moved onto the left l5 guide.After a thorough soft tissue dissection and an indicated osteotomy, he docked the guide and after introducing the drill and taking a flouro shot we saw that the trajectory was incorrect.He continued to do more dissection and took a second shot after docking the guide but the trajectory was still off.He decided at that point to freehand the screws.The surgeon decided to place the screws freehand.The issue caused 30-40 minutes delay; total surgery time 281 minutes.
Additional Manufacturer Narrative
Planning review and visual inspection performed by mysolution department.Our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.The fitting is very good, the guides are stable and have a univocal positioning.The result is identical from those reprinted previously in medacta headquarter, i.E., fully compliant.

• Brand Name: MYSPINE UNILATERAL LEFT GUIDE S01
• Common Device Name: SPINE SCREW PLACEMENT GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20031372
• Report Number: 3005180920-2024-00722
• Device Sequence Number: 3048138
• Product Code: PQC
• UDI-Device Identifier: 07630345786586
• UDI-Public: 07630345786586
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K231483
• 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): 08/22/2024

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: 12/17/2024
• Device Catalogue Number: 7.1027
• Device Lot Number: 13813S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male