MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA NEXTAR SPINE MUST SCREWDRIVER - SHORT; SPINE INSTRUMENT

Catalog Number	03.57.10.0173
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 03-october-2023.Lot 2252515: (b)(4) manufactured and released on 18-oct-2022.No anomalies found related to the problem.To date, three other similar events have been reported on the same lot during the period of review.Visual inspection performed by r&d project manager: from the information available and the device received, it is possible that there was a suboptimal preparation of the bone for the screw insertion (no tapping for the entire lenght of the screw was performed) that caused the tip's breakage.
Event or Problem Description
During a nextar case, while inserting s2ai screw (10x100mm), the tip of nextar spine must screwdriver - short broke.No screw was inserted in s2ai and the surgery was completed successfully.Tapping was performed using references 03.51.10.0438 -> 03.51.10.0439 -> 03.51.10.0440.All fragments were removed.Delay time 30 min.Total surgery time 7h.The delay was due to the time necessary to retrieve the fragments of the tip of screwdriver.
Additional Manufacturer Narrative
On 29 february 2024, during a check, we have found two errors in the initial mdr report (mdr 2023-00841): labeled for single use?: it is written "yes" but it has to be "no".Usage of device: it is written "initial use" but it has to be "reuse".

• Brand Name: NEXTAR SPINE MUST SCREWDRIVER - SHORT
• Common Device Name: SPINE INSTRUMENT
• 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: 18011498
• Report Number: 3005180920-2023-00841
• Device Sequence Number: 20702604
• Product Code: OLO
• UDI-Device Identifier: 07630345728968
• UDI-Public: 07630345728968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210859
• 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): 02/29/2024

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 Catalogue Number: 03.57.10.0173
• Device Lot Number: 2252515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian