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

Model Number N02 00011

Device Problems Break (1069); Difficult to Insert (1316); Off-Label Use (1494); Failure to Align (2522); Difficult to Advance (2920)

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

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

Batch record of the broken reusable instrument was reviewed and found to be compliant.Upon inspection of the part, wich was returned to in2bones sas, it appeared it was broken where it was the most mechanically challenged when associated with the other parts of the targeting jig.The instrument looks normal aroud the breakage area.However, it shows signs of impaction on a spot where it should not have been impacted, which explains the breakage observed.Indeed, it appears it was hit on the sides instead of being hit, as intended, on the center part to compresss the nail into the bone vertically.A dedicated instrument (masselotte) is supplied in the triway system to specifically enable a centered impaction, but it was not used by the surgeon.The associated instruction is clearly pictured in the surgical technique.This is the first occurrence of any type of incident linked to this instrument since the system was first cleared in 2018.This incident being the first occurrence and clearly being linked to user error, no field action is deemed necessary.In2bones sas will continue to monitor and record such events, if any.This emdr was initially prepared and sent to fda in 2019 (initial report on june 07).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 Description

Ankle surgery: the triway 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¿ 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 implated through the nail thanks to a dedicated targeting jig.To perform the compression maneuver of the tibiotalo joint, the surgeon hammered the jig and the hitting plate broke off into the connector (both components being parts of the jig).After this happened, the surgeon commented that the jig had approximately 10 to 15 degrees of play.As a consequence, the surgeon was unable to accurately line up the jig with the proximal nail holes and could not advance the 5.0 mm triway screws through the tibial nail holes.He was able to get the drill into the nail hole but not the screw.The surgeon, having difficulties inserting the screws in the nail, decided to use other screws (of the same diameter) he was familiar with, even though they were not part of the triway systrem, and were used off-label.The surgery duration was extended for about an hour.The hitting plate is a non-invasive instrument, and the broken part or any metallic debris could not come in contact with the patient.The surgeon stated the post-operative x-rays looked good.There was no other clinical consequences apart from the extension of the surgery duration.

• Brand Name: TRIWAY HITTING PLATE
• Type of Device: HITTING PLATE OF A TARGETING JIG
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; ecully, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONS SAS; 28 chemin du petit bois; ecully, 69130 ; FR 69130
• Manufacturer Contact: morgane grenier ; 28 chemin du petit bois; ecully, 69130 ; FR 69130
• MDR Report Key: 10940169
• MDR Text Key: 220223302
• Report Number: 3010470577-2019-05052
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 03760225717950
• UDI-Public: (01)03760225717950(10)1807079
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N02 00011
• Device Lot Number: 1807079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization