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

Catalog Number 03.57.10.0026

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/19/2024

Event Type  malfunction  

Event 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.

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.

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°
• Type of Device: 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
• MDR Text Key: 340695590
• Report Number: 3005180920-2024-00239
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07630971292499
• UDI-Public: 07630971292499
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K210859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 03.57.10.0026
• Device Lot Number: 2261237
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other