MAUDE Adverse Event Report: IN2BONES SAS TRIWAY HITTING PLATE; HITTING PLATE OF A TARGETING JIG

Model Number	N02 00011
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch record was reviewed and found to be compliant.Upon inspection of the part, which was returned to in2bones, it appeared to be broken where it is the most mechanically challenged when associated with the other parts of the targeting jig.This is the second occurrence of any type of incident linked to this instrument since the system was first cleared in 2018.This event is probably due to the recommendations not being adequately followed.The surgical technique manual indeed includes a statement that the tibial canal should be reamed 1mm above the desired nail diameter.If this step is carried out, no significant efforts are required to impact the nail in place.Only final adjustment is to be made with impaction on the hitting plate.However, in order to limit the risk of malfunction when surgical technique recommendations are not followed, a change control is being implemented to change the heat treatment applied on this instrument, and to improve its resistance to breakage.The engineering drawing was revised on may 27, 2019.The instrument involved was manufactured before the change implementation.No field action is deemed necessary.In2bones sas will continue to monitor and record such events, if any.A previous occurrence of a similar problem (medwatch report 3010470577-2019-05051) caused a one-hour increase in the surgery duration and was therefore reported.This is the reason why this second occurrence is also reported : even if it did not have any consequences for the patient, in2bones considered it could lead to a significant increase in surgery duration if it were to recur.This emdr was initially prepared and sent to fda in 2019 (combined report sent on august 08th, 2019).A failure occurred in webtrader electronic filing system but this was not detected by in2bones sas immediately.In november 2020, a webtrader certificate issue has been resolved and, at the same time, in2bones discovered the messages indicating the reception failures of some emdrs.In consequence, these emdrs were corrected and are now being filed retrospectively.
Event or Problem Description
Ankle surgery: the triway(r) ttc arthrodesis system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.Examples include: - post-traumatic and degenerative arthritis involving both ankle and subtalar joints - rheumatoid arthritis with severe deformity - revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body - revision of failed total ankle arthroplasty with subtalar intrusion - talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis) - neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, including charcot foot - severe pilon fractures with trauma to the subtalar joint - malunited tibial pilon fractures the in2bones triway(r) ttc arthrodesis nail has to be fixed with the associated: tibial fixation using cotter screws diameter 5.0mm ; talar fixation using cotter screws diameter 5.0mm ; calcaneus fixation using cotter screws diameter 5.0mm.The addition of an ibs" 6.5mm compression screw through the subtalar joint and through the nail is required.All screws are intended to be implanted through the nail thanks to a dedicated targeting jig.Event description: during a surgery with dr.(b)(6) the triway hitting plate broke.There were no patient complications reported and the surgery was completed successfully.A previous occurrence of a similar problem (in2bones internal reference (b)(4) caused a one-hour increase in the surgery duration and was therefore reported.This is the reason why this second occurrence is also reported : even if it did not have any consequences for the patient, in2bones considered it could lead to a significant increase in surgery duration if it were to recur.

• Brand Name: TRIWAY HITTING PLATE
• Common Device Name: HITTING PLATE OF A TARGETING JIG
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 10940182
• Report Number: 3010470577-2019-07142
• Device Sequence Number: 16940442
• Product Code: FZX
• UDI-Device Identifier: 03760225717950
• UDI-Public: (01)03760225717950(10)1802050
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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
• Operator of Device: Health Professional
• Device Model Number: N02 00011
• Device Lot Number: 1802050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1