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 Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 55008 lot e50 (lot laser marked on component 550030) before the market release.No anomalies have been found.The original lot manufactured in year 2016 was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint notified from this specific device lot.Technical evaluation the device involved in this event has not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the device concerned.The technical evaluation of the device involved will be performed as soon as the device become 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 technical evaluation are available.As soon as the results of the investigation and/or further information are available, orthofix srl will provide you with 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); surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; revision done on (b)(6) 2017; body part to which device was applied: lt femur.Surgery description: lengthening.Patient's information: (b)(6) years old, female; condition patient was being treated for: lt femur lengthening problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: per representative 55008 compression distraction unit failed to keep the clamps in place.On around the 8th week x-rays were taken and showed it was collapsed.Patient had a second surgery to correct the problem and replace the unit.The initial surgery was uneventful and appeared to go as planned.The complaint report form indicates: -the device failure had adverse effects on patient; -the surgery was completed with used device; -an additional surgery was required following device failure -(b)(6) 2017; -copies of the operative report are not available; -copies of the x-ray images are available; information on patient current health condition: unavailable further information received from the distributor on april 12, 2017: -copy of x-ray images, showing from week 10 then week 11 (according to representative) -the defective device was replaced with a new 55008.The representative is waiting to hear back from the doctor on patient's current condition.Further information received from the distributor on april 24, 2017: -lot number of the item involved: e50.(b)(4).

Manufacturer Narrative

Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 55008 lot e50 (lot laser marked on component 550030) before the market release.No anomalies have been found.The original lot manufactured in june 2016 was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint notified from this specific device lot.Technical evaluation the returned device, received on may 2nd, 2017 was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and dimensional check as per orthofix (b)(4) specification.The visual and dimensional check did not evidence any anomalies.The functional check confirmed that the device is functioning properly.It can run the full travel without any anomalies and it can hold a load applied by hand on all the threaded length.The technical analysis performed confirmed that the device was originally conforming to design specifications and that it still performs properly.No anomalies were detected.The failure occurred could be related to the conditions of use of the device.Medical evaluation: the information made available on the event, together with the results of the technical analysis was sent to our medical evaluator.Please find below an extract of the medical evaluation performed.On 18 april 2017 "in this case a cd unit 55008 was being used to distract the femur of a (b)(6) girl.Lengthening was proceeding when it was noted that the cd unit appeared not to be functioning and the lengthening had been lost.During a second surgery a new unit was applied and lengthening is continuing.There are 2 x-rays which show in one a femur being lengthened with a bone gap of around 22 - 25 mm with some regenerate bone in the gap, and in the other the same frame but with no lengthening.There is no way of knowing the time relationship between the two.So the suggestion is that the cd unit has collapsed." on 09 may 2017 "the technical analysis makes it very clear that this cd unit is working normally.There was no reason for the device to collapse if it remained in situ.Therefore, there must have been some local cause for the loss of position not related to the normal functionality of the device.I notice in the photograph that the 'o' ring on the left hand location pin seems a little damaged.I wonder if the cd unit became detached from the lrs clamps at some stage, possibly during some activity.I agree with the conclusions of the technical analysis." final comments: the technical analysis performed confirmed that the device was originally conforming to design specifications and that it still performs properly.No anomalies were detected.The failure occurred could be related to the conditions of use of the device.The medical evaluation evidenced as follows: "the technical analysis makes it very clear that this cd unit is working normally.There was no reason for the device to collapse if it remained in situ.Therefore, there must have been some local cause for the loss of position not related to the normal functionality of the device.I notice in the photograph that the 'o' ring on the left hand location pin seems a little damaged.I wonder if the cd unit became detached from the lrs clamps at some stage, possibly during some activity.I agree with the conclusions of the technical analysis." based on the results of the technical evaluation performed on the returned device, that evidenced its conformity to orthofix (b)(4) specifications and that it is still fully functioning, orthofix (b)(4) can conclude that the problem occurred is not device related.Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: university medical center; surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; revision done on (b)(6) 2017; body part to which device was applied: lt femur.Surgery description: lengthening.Patient's information: (b)(6), female; condition patient was being treated for: lt femur lengthening.Problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: per representative 55008 compression distraction unit failed to keep the clamps in place.On around the 8th week x-rays were taken and showed it was collapsed.Patient had a second surgery to correct the problem and replace the unit.The initial surgery was uneventful and appeared to go as planned.The complaint report form indicates: -the device failure had adverse effects on patient; -the surgery was completed with used device; -an additional surgery was required following device failure - (b)(6) 2017; -copies of the operative report are not available; -copies of the x-ray images are available; information on patient current health condition: unavailable.Further information received from the distributor on april 12, 2017: -copy of x-ray images, showing from week 10 then week 11 (according to representative) -the defective device was replaced with a new 55008.The representative is waiting to hear back from the doctor on patient's current condition.Further information received from the distributor on april 24, 2017: -lot number of the item involved: e50.On may 11, 2017 the distributor confirmed that no further information will be made available on this event.(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
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012 ; 0456719000
• MDR Report Key: 6536316
• MDR Text Key: 74145242
• Report Number: 9680825-2017-00025
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 55008
• Device Catalogue Number: 55008
• Device Lot Number: E50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR