MAUDE Adverse Event Report: APIFIX LTD. MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 125

Device Problem Break (1069)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures,and shipped according to manufacturer's specifications.Surgeon, x-ray, information analysis: on (b)(6) 2023, apifix was notified that patient #(b)(6) underwent revision surgery for reasons unspecified.Apifix followed up for more information which was provided.The reason for revision was a broken apifix bolt, mid shank; patient symptoms were pain and discomfort.Per the reporter, upon extraction the polyaxial joint appeared "frozen" which may have led to additional stress on the apifix bolt.Risk assessment: screw fracture/breakage is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally section.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of screw breakage has been quantified, characterized, and documented as acceptable within full risk assessment.Device was returned to manufacturer on 09-aug-2023; a failure analysis will be conducted.When further relevant information is identified with which to determine a cause, the complaint file will be updated and a supplemental medwatch will be filed.

Event Description

On (b)(6), 2023, apifix was notified that patient #(b)(6) underwent revision surgery due to a broken apifix bolt, mid shank.

Manufacturer Narrative

Device was returned to manufacturer for analysis.Engineering analysis: the explanted device was returned to manufacturer and was subjected to cleaning, steam sterilizing, and engineering evaluation.The reason for removal was obvious, as the apifix screw was broken.It was noted that the polyaxial joint was locked and this likely contributed to the fracture of the screw.The fracture plane was analyzed via microscope and showed indications that the fracture mode was likely fatigue and the fracture initiated at the root radius of the thread.Indications of a likely fast fracture were identified.This was likely what fractured during the final breakage event of the screw.The screw was disassembled and the spherical ring removed from the device.There was a significant build up of tissue debris on the threads of the screw and within the spherical ring housing.Removal of the spherical ring was challenging due to the polyaxial being difficult to rotate.Once freed and cleaned the joint moved more freely but still would get stuck.After removing the spherical ring again, it was observed that there was deformation at the edge of the spherical ring housing into the space where the spherical ring rotates.This material deformation likely occurred when the screw impinged against the spherical ring housing at the extreme end of polyaxial motion.Using a file to remove material from the raised, deformed area permitted more free rotation of the spherical ring.Therefore, the most likely conclusion is that the polyaxial joint reached end of travel with significant force, which damaged the housing and caused the polyaxial joint to lock.The locked polyaxial joint then likely caused more force in the screw, leading to its eventual fracture.There were no obvious manufacturing or design defects which contributed to the failure.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 17537677
• MDR Text Key: 321722835
• Report Number: 3013461531-2023-00031
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-01-069-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female