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

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	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During nextar surgery, the tip of screwdriver broke during pedicle screw 8.0x85mm insertion.Tapping 8.0 was performed initially.It took time to retrieve the broken piece from the pedicle screw head, but finally pedicle screw was able to retrieve.Additional tapping performed and the surgery finished with pedicle screw 8.0x75mm.Backup screwdriver (same lot) successfully used.Delay time 40 min to retrieve the broken part of the screwdriver and revise the pedicle screw.Total surgery time about 4 hours and 30 min.
Additional Manufacturer Narrative
Batch review performed on 15 january 2024.Lot 2252515: (b)(4) items manufactured and released on 18-oct-2022.No anomalies found related to the problem.To date, four other similar events have been reported on the same lot.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&spine project manager on (b)(6) 2024: the screwdriver's tip is broken most probably because the bone tapping was not performed for the entire depth (85mm) necessary to insert the enh poly-axial pedicle screw - cannulated 8x85mm.Corrections.H1 is malfunction.H5 is no.

• Brand Name: NEXTAR SPINE MUST SCREWDRIVER - SHORT
• Common Device Name: INSTRUMENT FOR SPINE SURGERIES
• 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: 18543116
• Report Number: 3005180920-2023-01111
• Device Sequence Number: 15723454
• 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): 02/14/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2024
• Supplement Date Received by Manufacturer: 12/28/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/14/2024
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian