MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA NEXTAR SPINE DOUBLE SHORT CLAMP 25°; INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.57.10.0026
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During nextar spine surgery, after 4 k-wires (used for pedicle screw insertion guide) have been positioned, the nextar spine double short clamp 25° was not stable anymore on the bone and some movements of it have been detected.When the surgeon tried to reposition the clamp, it was not possible to mount it newly on the patient's bone.The screw of the clamp was blocked.Therefore, the surgeon positioned the long clamp 25° (alternative instrument) on the same processus spinous to insert 2 additional k-wires and in that moment, a fracture of the processus spinous has been detected in th5/th6.The patient's bone quality was poor and severely osteoporotic.The conventional instrumentation was used to reposition the 2 k-wires and finish the surgery.The surgeon decided to not fix the fracture and to close the patient.Delay time is approximately 15 minutes.
Additional Manufacturer Narrative
Batch review performed on 15 january 2024: lot 2261237: (b)(4) manufactured and released on 04-may-2023.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Visual inspection performed by medacta nextar r&d project manager: the cap of the clamp was not fixed because probably during the tightenening of the clamp to the spinous process, the pin which keeps together the cap of the clamp to its shaft was broken leading to the separation of the 2 components.In order to improve the stability and resistance of the coupling between the components (cap and shaft), a design modification was applied by means of mr008-23 which implement a squadre interface between the cap of the clamp and its shaft.
Additional Manufacturer Narrative
During a check performed on 29 february 2024 medacta recognize the following correction to be performed on the mdr 2024-00023.D9 'returned to manufacturer' has to be flagged and the returnd device date to be inserted.The return date is 01-18-2024.H3 'device evaluated by manufacturer' is yes.The device analysis perfomed by manufacturer is alreay in the initial mdr 2024-00023.

• Brand Name: NEXTAR SPINE DOUBLE SHORT CLAMP 25°
• Common Device Name: INSTRUMENT FOR SPINE SURGERY
• 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: 18648847
• Report Number: 3005180920-2024-00023
• Device Sequence Number: 12540434
• Product Code: OLO
• UDI-Device Identifier: 07630971292499
• UDI-Public: 07630971292499
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.57.10.0026
• Device Lot Number: 2261237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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