MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X); SPINE CERVICAL PLATE

Model Number	03.70.018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 january 2022: lot 1822488: (b)(4) items manufactured and released on 23-dec-2020.Expiration date: 2025-dec-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
During the 3-level acdf (from 4 to 7) procedure when the surgeon was implanting the screws, one screw broke during implantation.The surgeon then proceeded to implant another screw which also broke.The agent provided the surgeon with a screw removal kit and the surgeon was able to remove one of the screws and implant a new one in its place.The other screw (on c4) remained as the surgeon was not able to remove it.There was a 40-minute delay and the surgery was completed successfully.A loaner set was utilized.The patient had a hard bone.Additional anesthesia was administered.Total surgery time 2 hours 45 minutes.
Additional Manufacturer Narrative
Investigation performed by r&d with the available info on 19 april 2022: based on the available information reported in this event, it was assumed that it was difficult to position the screws because bone density was hard.During the procedure it is always recommended to prepare the pilot hole with drilling and tapping, in order to ease screw positioning while avoiding unexpected failure.The combination of not tapping and hard bone arises the probability of screw damage and failure.In fact, these circumstances can generate potential torsional stress at the implant-instrument interface that might lead to breakage.The instrument set is provided with a modular rigid screwdriver and inner shaft (ref.03.70.10.0060 & 03.70.10.0058) that can be fully secured with the screw bone, after the removal of the small locking screw.This screwdriver provides superior stability of the screw during positioning while reducing the toggle and the stress at the interface.The procedure for this driver is explained in the related surgical technique.Additionally, the instrument set includes instruments that can be used for screw removal in case of failure: screw removal (ref.03.70.10.0002) and the locking screw extractor (ref.03.70.10.0022).Those instruments were specifically designed for that purpose.It was reported that after the first screw positioning and removal, after tapping, the following screw positioning was done with no issue.For what concern the broken screw that remained in the patient, it was reported that it stands fully seated in the plate hole and did not protrude from the plate.In this circumstance screw migration cannot be predicted, even considering that the screw struggle to advance due to hard bone and that it was not possible to remove it at all.Section h1 was modified in malfunction.

• Brand Name: CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)
• Common Device Name: SPINE CERVICAL PLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13505837
• Report Number: 3005180920-2022-00117
• Device Sequence Number: 12093557
• Product Code: KWQ
• UDI-Device Identifier: 07630030840029
• UDI-Public: 07630030840029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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 Expiration Date: 12/03/2025
• Device Model Number: 03.70.018
• Device Catalogue Number: 03.70.018
• Device Lot Number: 1822488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown