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

Model Number MID-C 125

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 apifix was notified that patient #(b)(6) (pas# (b)(4).Is scheduled for revision surgery on (b)(6) 2023 due to ratchet malfunction.Patient's mother states they are completely asymptomatic.

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, information analysis: on (b)(6) 2023 apifix was notified that patient #(b)(6) (pas# (b)(4) was scheduled for revision surgery on (b)(6) 2023 due to ratchet malfunction.Patient's mother stated they were completely asymptomatic.On (b)(6) 2023 patient #(b)(6).Underwent revision surgery as planned.No report of patient harm/complications was received.Corrective action: ratchet malfunction (resulting in a backup of the distraction) can result from physical trauma, practicing high-demand sports, and tissue growth inside the ratchet mechanism.Ratchet malfunction may be a coincidental finding and may also be reported together with pain/curve progression/noise.The company took several actions to mitigate ratchet malfunction: eco-13, the ratchet flat spring component was changed to a thicker spring (from 0.15 to 0.25mm).Eco-59, addition of a stopper pin to prevent the pole from dislocating from the base and inherit from the design to prevent the collapse of the ratchet.In (b)(6) 2020, a highlight of the risk associated with practicing high-demand sports was added to the mid-c training presentation.The company continues to monitor the effectiveness of the mitigations.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.The risk of the ratchet malfunction has been assessed and found to be acceptable.The risks have been quantified, characterized, and documented as acceptable within full risk assessment the device is expected to be returned to manufacturer for analysis.When further relevant information is identified with which to determine a cause, a supplemental report will be filed.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.During the inspection, the device's ratcheting mechanism did not appear to be functioning properly.Specifically, when the control pin was in ratchet position (arrow of control pin aligned with arrow on device body) the device should "click" upon lengthening and allow no shortening.However, upon applying an axial load the device could be easily shortened.The exact cause of this malfunction could not be investigated because the internal mechanism is sealed by permanent closure (weld).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 street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 17906597
• MDR Text Key: 325305850
• Report Number: 3013461531-2023-00047
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-07-036-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• 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