MAUDE Adverse Event Report: ORTHOFIX SRL LONG C/D CLICKER MODEL

Model Number 50009

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 50009 lot e88 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of 149 devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint received in regards to this specific device lot.Technical evaluation: the returned device, received on may 11, 2017 was examined by orthofix (b)(4) quality engineering area.The device was subjected to visual, dimensional and functional check as per orthofix (b)(4) specification.The visual check did not evidence any anomalies.All external components are present.C/d unit pins, hexagonal part of the device, clicker mechanism are in conformity with specifications.The functional check could not be performed as male and female components of the device are gripped, therefore, they could not be moved or separated.The functional check of the clicker confirmed that it works properly.The dimensional check performed on the threaded part not covered by the female component, did not evidence any anomalies.The dimensional check on central threads could not be performed as they are gripped (as the device is sized up).Medical evaluation: the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed."a distractor was used on this patient initially; "the patient did the lengthening until the end of distractor"; it was lengthened until it "was in two part"; it was then changed to a 50009 cd unit, which was apparently adjusted initially and fitted to the lrs, but was then found to be immovable.A 50009 cd unit has been returned, and has been found to be seized up so it cannot be moved.Except for this fact the returned unit is to specification.The reason for it being jammed has not been evaluated.The report is also definite that the complainant changed a distractor.I think that events were as follows: lrs fixator applied with a short cd unit for lengthening on (b)(6) 2017.The cd unit was lengthened to the end and then changed to a 50009 ((b)(6)).The cd unit was distracted until it separated into 2 parts.The representative changed the cd unit the next day and it continues towards a goal of 12 cm.Perhaps the returned cd unit was distracted to separation and the surgeon then joined the parts up but they jammed." on may 24, 2017 with the further information provided on may 23, 2017 "we have very definite evidence that the longer distractor, 50009, was over distracted past the stop and separated into two parts.This happens when the remaining length after the cd unit is applied is not measured precisely and the patient is not warned to return before a certain date.We know that this cd unit was separated by being over distracted, and we are told that the surgeon joined the pieces up again.This will be why it is now jammed." final comments: from the results of the technical evaluation, it was concluded that the device was originally conforming to specifications.The failure occurred could be mainly attributable to the conditions of use of the device, but as the technical analysis could not identify a specific failure mode, it is not possible to determine the root cause of the event notified.The medical evaluation evidenced as follows: i think that events were as follows: lrs fixator applied with a short cd unit for lengthening on (b)(6) 2017.The cd unit was lengthened to the end and then changed to a 50009 ((b)(6)).The cd unit was distracted until it separated into 2 parts.The representative changed the cd unit the next day and it continues towards a goal of 12 cm.Perhaps the returned cd unit was distracted to separation and the surgeon then joined the parts up but they jammed." we have very definite evidence that the longer distractor, 50009, was over distracted past the stop and separated into two parts.We know that this cd unit was separated by being over distracted, and we are told that the surgeon joined the pieces up again.This will be why it is now jammed." a complete medical evaluation was not performed as some information about the medical procedure was not made available, i.E.X-rays of the case.Orthofix (b)(4) historical records shows that no other notifications have been received in regards to this specific device lot.Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6); surgeon name: prof.(b)(6); date of initial surgery: n/a; body part to which device was applied: femur lrs; surgery description: lengthening; patient information: n/a; problem observed during: n/a; type of problem: n/a.Event description: we use a lrs for a lengthening of the femur, the patient did the lengthening until the end of distractor, then get to the surgeon visit, the surgeon called me that the distractor was in two part, i told him to try to put together the two part and i ll change the tube to continue the lengthening, i changed the distractor and we change the position on the lrs to continue the distraction, but this distractor is destroy and i just want that you put an eye on and let me know what's going up and why the distractor can be disassembled, because normally, you cannot you have a stop.On may 22, 2017, orthofix (b)(4) received the following additional information: -date of initial surgery: (b)(6) 2017 uni lausanne.-date of device failure: (b)(6): first we did the lengthening with a short distractor, as soon as we finish, we changed the strut to a long one and then the surgeons went to the end of the compressor and it went in 2 parts.He tried to reconnect it, but couldn't do it well, i went to change the compressor the same day.-date of device replacement: (b)(6).-planned lengthening: total want to do 12 cm.-lengthening achieved before device failure: already 8 cm.-patient information (age, sex and weight): (b)(6) male - (b)(6).-did device failure have any adverse effects on patient? no, except he had to come back the day after.-was an additional surgery required to replace the device? no.-copies of the operative report and copies of the pre and post-operative x-rays: n/a.-patient current health condition: good.On may 23, 2017, orthofix (b)(4) received the following additional information: "first of all, we apply a short distractor to start the bone transport, then we change to a long one, at the end of the long one, the distractor get in 2 parts.The surgeons called me to ask me if that was normal, i said normally not, but asked him if he could rebuilt together the 2 part until i bring him another long distractor.On may 2 we put the long compressor in the 2 extern hole of the advanced straight clamp (53530) and then we change to put in the two internal holes." (b)(4).

• Brand Name: LONG C/D CLICKER MODEL
• Type of Device: LONG C/D CLICKER MODEL
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012 ; 0456719000
• MDR Report Key: 6593526
• MDR Text Key: 76030120
• Report Number: 9680825-2017-00034
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50009
• Device Catalogue Number: 50009
• Device Lot Number: E88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 70