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 Failure of Implant (1924)

Event Date 03/04/2023

Event Type  malfunction  

Event Description

On 04-mar-2023 apifix was notified that patient (b)(6) is undergoing revision surgery on (b)(6) 2023 due to alleged ratchet malfunction.

Manufacturer Narrative

Production process analysis: 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.User (surgeon and patient) information analysis: patient (b)(6) index procedure was performed on (b)(6) 2021.On 04-mar-2023 apifix was notified that patient (b)(6) is undergoing revision surgery on (b)(6) 2023 due to alleged ratchet malfunction.X-ray images of the index surgery ((b)(6) 2021) vs.X-rays from a 2 year follow up ((b)(6) 2023) were provided which allege the ratchet malfunction (back-up).On (b)(6) 2023 the patient was revised.The 6.5x40mm distal apifix screw was replaced with a 7.0x40mm apifix screw.The 125mm mid-c lp was replaced with a standard 125mm implant.The extender lenke 5 was replaced with a lenke 1 left to achieve better convergance with the anatomy and it was moved one level down to avoid full extension. no report of patient harm or complications was received.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of the ratchet malfunction has been assessed and found to be acceptable.This event does not increase the probability rating.The total rate of ratchet malfunction for any reason is (b)(4).The risk have been quantified, characterized, and documented as acceptable within full risk assessment.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 march 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 mitigation's.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics in warsaw, in and was evaluated.The spherical rings were inspected and no obvious signs of wear was observed.Upon receipt the control pin was stuck and unable to be moved.After working the control pin repeatedly, the device mechanism seemed to operate more freely.At this point the ratchet malfunction was able to be repeated and the device was able to be shortened from full extension to the length shown in x-ray.The exact cause of this could not be investigated because the internal mechanism is sealed by permanent closure (weld).Ratchet malfunction (resulting in 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 best assumption from similar past similar cases was that tissue growth into the ratchet mechanism was the reason for the problem.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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: 16634937
• MDR Text Key: 312217093
• Report Number: 3013461531-2023-00006
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2023

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 Model Number: MID-C 125
• Device Catalogue Number: AFL-125-050
• Device Lot Number: AF-12-065-20
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 03/04/2023
• Supplement Dates FDA Received: 07/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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: 17 YR
• Patient Sex: Female