MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40; SACRO ILIAC SCREWS

Model Number	03.65.704
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 february 2021: lot 1923300: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional items involved in the event, batch review performed on 01 february 2021: sacro-iliac screw system 03.65.913 favored angle washer ø17mm, ti (k171595) lot.1924155 lot 1924155: (b)(4) items manufactured and released on 15-apr-2020.Expiration date: 2025-03-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery 1 month after primary surgery for screw malpositioning.The screw was implanted 2mm too deep into the bone during the primary lead to contact with nerve root l5.During revision, the screw came out very easily, but the washer needed several extraction attempts to be revised.Finally removed using forceps.
Additional Manufacturer Narrative
Device returned on 17-feb-2021 and analyzed on 23-feb-2021.Visual inspection performed by r&d project manager.Visual inspection performed on the 23rd february 2021.During a revision surgery, according to the complaint information, the si-joint screw was extracted very easily, but the washer remained in place.Must si-joint screws and washers are designed to be intraoperatively assembled by means of a dedicated instrument before their insertion into the bone; once assembled, implant designs (interference between screw head external surface and washer inner cavity) ensure that the washer can freely rotate around the screw head, but their disassembling is avoided.Their disassembling requires an high axial force that cannot be manually applied.The received implants have been inspected and their coupling surfaces are inside drawing tolerances (screw ø10.44mm - washer 10.34mm - interference of 0.10mm).They have been successfully and easily assembled with the dedicated instrument (03.65.10.0035), and it was possible to disassemble them only using an hammer in more than one attempts.For these reasons, the potential root cause could be the not proper and complete screw-washer assembling during the primary surgery, that led to the unexpected disassembling during the revision surgery.

• Brand Name: SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40
• Common Device Name: SACRO ILIAC SCREWS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11284922
• Report Number: 3005180920-2021-00087
• Device Sequence Number: 3498752
• Product Code: OUR
• UDI-Device Identifier: 07630030881084
• UDI-Public: 07630030881084
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 03/18/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2025
• Device Model Number: 03.65.704
• Device Catalogue Number: 03.65.704
• Device Lot Number: 1923300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/18/2021
• 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: Required Intervention
• Patient Age: 83 YR