MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM; SPINE SACRAL ILIAC SCREW

Model Number	03.65.659
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the primary spine surgery, when the surgeon was tapping the s2ai screw, he could only get the screw to seat 80%.When he tried to remove the screw with the screwdriver, the screwdriver broke.The surgeon tried another screwdriver to remove the screw which also broke.The surgeon took a saw and cut the head off the screw and left the shaft in the patient.Additionally, on the si screw, the surgeon tried to advance the screw, and the implant failed 1/3 of the way down.The implant sheard off inside the driver.There was a 45-minute delay, and the surgery was completed successfully.A consignment set was utilized.
Additional Manufacturer Narrative
Batch review performed on 08 october 2024.Lot: 2124492: (b)(4) items manufactured and released on 29-mar-2022.Expiration date: 2027-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: pedicle screw must s2ai ha screw ø8x80 std full thread (k234048) lot: 2328888: (b)(4) items manufactured and released on 15-mar-2024.Expiration date: 2029-03-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Additional Manufacturer Narrative
There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Additional Manufacturer Narrative
Correction: h8 initial use.

• Brand Name: M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM
• Common Device Name: SPINE SACRAL ILIAC SCREW
• 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: 20464547
• Report Number: 3005180920-2024-00837
• Device Sequence Number: 7368902
• Product Code: OUR
• UDI-Device Identifier: 07630971251496
• UDI-Public: 07630971251496
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.65.659
• Device Lot Number: 2124492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/15/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2022
• 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 Sex: Unknown