MAUDE Adverse Event Report: ORTHOFIX SRL PAEDIATRIC LRS C/D UNIT EXTENDS TO 6.2 CM

Model Number 55008

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records the affected device involved in this event has not been returned yet to orthofix srl.Unfortunately, the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation the affected device involved in this event has not been returned to orthofix srl yet.The technical analysis will be performed as soon as the device is made available.Medical evaluation the information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the event investigation become available.As soon as the results of the investigation are available, orthofix srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name.(b)(6) medical center surgeon name.(b)(6) date of initial surgery.(b)(6) /2020.Body part to which device was applied.Left humerus surgery description.N/a patient information.6 (b)(6), male problem observed during.Clinical use on patient intraoperative type of problem.Device functional problem event description.Product's extension component will not work the complaint report form also indicates.The device failure had no adverse effects on patient the initial surgery was completed with the device the event did not lead to a delay in the duration of the surgical time an additional surgery was not required a medical intervention (outpatient clinic) was not required copy of operative reports is not available copy of x ray images is not available patient current health conditions.N/a note and comments: product will be available for return after replacement component is shipped and replaced.Manufacturer reference number.(b)(4).Distributor reference number.(b)(4).

Manufacturer Narrative

Analysis of historical records: the affected device involved in this event has not been returned yet to orthofix srl.Unfortunately, the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: a technical evaluation of the device used was not performed as the device has not been made available for the investigation.The technical evaluation will be performed as soon as the device become available.Medical evaluation: the information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluation performed.A 6 year old boy has a cd unit 55008 attached to a fixator on his left humerus.The cd unit malfunctioned at some stage and we are told that a replacement is being shipped out.My concern here is that we do not know the pathology here or the type of fixator applied.At his age if the interval between non function and replacement of the fixator is longer that 7 days the osteotomy (if there is one) may heal, and for treatment to continue the patient will then require a second osteotomy.This is only one scenario but a possible one.Yes it will be possible to replace the cd unit in outpatients, but if a repeat osteotomy is required.I therefore suggest that we report this as a product problem.Final comments: a technical evaluation of the device used was not performed as the device has not been made available for the investigation.Unfortunately, no information about lot involved is available, therefore it is not possible to perform any technical investigation.A complete medical evaluation was not performed as no information about the medical procedure, diagnosis and x-rays have been made available.Orthofix srl has requested further information on the event such as batch number of the device, date of the device replacement, confirmation that the device was replaced at the doctor's office (outpatient clinic), copy of x-ray images, patient's current health condition and the device availability for the technical evaluation.Unfortunately, this information has not been made available.Considering the lack of information, it is not possible to conduct any investigation and therefore to draw any conclusion in regards to the complained c/d unit.Should further information and/or the device concerned become available, orthofix srl will re-open the investigation.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6) medical center.Surgeon name: (b)(6).Date of initial surgery:(b)(6) 2020.Body part to which device was applied: left humerus.Surgery description: n/a.Patient information: 6 year-old, male.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: product's extension component will not work.The complaint report form also indicates: the device failure had no adverse effects on patient.The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical time.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copy of operative reports is not available.Copy of x-ray images is not available.Patient current health conditions: n/a.Note and comments: product will be available for return after replacement component is shipped and replaced.Manufacturer reference number: (b)(4).Distributor reference number:(b)(4).

• Brand Name: PAEDIATRIC LRS C/D UNIT EXTENDS TO 6.2 CM
• Type of Device: PAEDIATRIC LRS C/D UNIT EXTENDS TO 6.2 CM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 11192819
• MDR Text Key: 245851475
• Report Number: 9680825-2021-00008
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55008
• Device Catalogue Number: 55008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Patient Sequence Number: 1
• Patient Age: 6 YR