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

Catalog Number	03.57.10.0026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The fixation screw of the nextar spine double short clamp 25° was broken and it was not possible to remove the clamp at the end of the surgery.It has been necessary to break the spinous process in order to remove the instrument.The delay time was 30/40 minute and the total time of the surgery was 4h.
Additional Manufacturer Narrative
Batch review performed on 03-apr-2024: lot 2261237: (b)(4) items manufactured and released on 04-may-2023.No anomalies found related to the problem.To date, (b)(4) other similar events have been reported on the same lot during the period of review.Visual inspection performed by medacta spine r&d project manager: from the pictures is difficult to see the malfunctioning but most probably the cap of the clamp could be 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 broke leading to a suboptimal coupling between the 2 components.In this case to remove the clamp, it is necessary to unscrew the clamp by means of a forceps.In order to improve the stability and resistance of the coupling between the components (cap and shaft), a design modification was applied, an implement of the squadre interface between the cap of the clamp and its shaft.
Additional Manufacturer Narrative
Piece returned on 17 april 2024.Visual inspection performed by r&d project manager: the cap of the clamp was not fixed because probably during the tightening of the clamp to the spinous process, the pin which keeps together the cap of the clamp to its shaft broke, leading to a suboptimal coupling between the 2 components.

• Brand Name: NEXTAR SPINE DOUBLE SHORT CLAMP 25°
• Common Device Name: SURGICAL 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: 19085957
• Report Number: 3005180920-2024-00239
• Device Sequence Number: 7099875
• Product Code: OLO
• UDI-Device Identifier: 07630971292499
• UDI-Public: 07630971292499
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K210859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 03.57.10.0026
• Device Lot Number: 2261237
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown