MAUDE Adverse Event Report: ORTHOFIX SRL STRAIGHT CLAMP FOR PAEDIATRIC LRS

Model Number 55050

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records (please also kindly refer to mfr report 9680825-2017-00045, mfr report 9680825-2017-00046 and mfr report 9680825-2017-00048).Orthofix srl checked the internal records related to the controls made on the device code 55080 lot v1427011 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.Orthofix srl checked the internal records related to the controls made on the device code 55050 lot v1429875 (lot v1427039, laser marked on component 550010) 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.The device reference 55008 involved in this event was not returned to orthofix srl.Unfortunately also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation (please also kindly refer to mfr report 9680825-2017-00045, mfr report 9680825-2017-00046 and mfr report 9680825-2017-00048).The technical evaluation of the returned devices, received on june 7, 2017, is ongoing.Medical evaluation (please also kindly refer to mfr report 9680825-2017-00045, mfr report 9680825-2017-00046 and mfr report 9680825-2017-00048).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 a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: (b)(4).Batch number: unknown; quantity: 1 & 2 & 1; hospital name: (b)(6); surgeon name: dr.(b)(6); date of initial surgery: no response provided; body part to which device was applied: tibia; surgery description: lengthening; patient information: no response provided; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: the rail completely backed up and compressed while on the patient during a lengthening.While the fixator was on the patient it collapsed after and during distraction.It happened on 3 different occasions, once in the beginning while the started distraction and twice while they were out to distraction.The first time the patient had the proximal clamp tight, the distal clamp lose and the cd unit attached.The third time both clamps were tight and the cd unit was removed and it still collapsed from the patient walking.The patient had to be brought back to the or 2 times, once for an adjustment to get back to length and the last time to remove the orthofix fixator and replace it with smith & nephew fixator.The complaint report form indicates: -the device failure had adverse effects on patient; further information received from the distributor on june 5, 2017: -this complaint fc 264835 is for the same patient of fc 264324, orthofix srl ref.201700043 (orthofix srl mfr report number 9680825-2017-00025 follow up 1, dated may 23, 2017) -the rail and the clamp have been shipped.The surgeon did not want to return the cd part number 55008.-the operative and x-ray images are not available.Please reference previous complaint information: -date of initial surgery: (b)(6) 2016.-patient information (age, sex and weight): (b)(6) female.-patient diagnosis: left femur lengthening.-date of the first revision surgery: (b)(6) 2017.-the orthofix fixator was removed and replaced it with smith & nephew fixator.-date of the second revision surgery (b)(6) 2017.Manufacturer reference number: (b)(4).Distributor reference number : (b)(4).Please also kindly refer to mfr report 9680825-2017-00045, mfr report 9680825-2017-00046 and mfr report 9680825-2017-00048.

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 55080 lot v1427011 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 notification received on this specific device lot.Orthofix srl checked the internal records related to the controls made on the device code 55050 lot v1429875 (lot v1427039, laser marked on component 550010) 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 notification received on this specific device lot.The device reference 55008 involved in this event was not returned to orthofix srl.Unfortunately, also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation on june 7, 2017, orthofix srl received from the distributor the following devices: 1 long rail length 25 cm for paediatric lrs code 55080 (instead of 1 x 55070 standard rail length 20 cm for paediatric lrs as originally communicated), and 2 straight clamp for paediatric lrs code 55050.The returned devices, were examined by orthofix srl quality engineering department.The devices were subjected to visual check as per orthofix srl design and product specifications.The visual check of the assembly did not evidence any anomalies, except from some residuals of tape on the rail.The assembly was then disassembled to check the single components.The visual check on single components evidenced that they appear damaged and worn with signs of debris between the screw and the washer.In the dimensional check of the devices no anomalies were detected.The devices passed all the functional checks performed.On the basis of the original controls and of the controls performed on returned devices orthofix srl technical analysis can conclude that the devices are still working properly.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 evaluations performed."a patient was having lengthening on a tibia using the paediatric lrs system.Apparently length was lost on 3 separate occasions; twice when lengthening was being carried out with a cd unit and so one clamp was loose, and once when both clamps were locked and the cd unit removed.We know nothing about the stature of the patient or the frame configuration, and you have asked for this.After the third failure the frame was changed for another system from a different company.These failures involved the whole system rather than a single component and it is very likely that the causes were technical relating to the particular case and surgeon." additional evaluation based on the results of the technical analysis: "this is an excellent technical analysis and the returned items have been tested completely, also against new comparable items from warehouse stock.The technical analysis makes it clear that the rail has been used before, probably several times, and that the function might therefore be affected.It seems that the rail should have been discarded because it has been subject to sufficient wear and tear to affect the performance, and this was obvious from a close inspection." final comments the results of the technical evaluation evidenced that the devices returned are still working properly.The failure occurred could be mainly attributable to the conditions of use of the devices.The medical evaluation evidenced as follow: a patient was having lengthening on a tibia using the paediatric lrs system.Apparently length was lost on 3 separate occasions; twice when lengthening was being carried out with a cd unit and so one clamp was loose, and once when both clamps were locked and the cd unit removed.We know nothing about the stature of the patient or the frame configuration, and you have asked for this.After the third failure the frame was changed for another system from a different company.These failures involved the whole system rather than a single component and it is very likely that the causes were technical relating to the particular case and surgeon.Based on the results of the technical evaluation performed on the returned devices, orthofix srl can conclude that the problem occurred could be mainly attributable to the conditions of use of the devices.Orthofix srl continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2017-00045 follow up 1, mfr report 9680825-2017-00046 follow up 1 and mfr report 9680825-2017-00048 follow up 1.- (b)(4).

Event Description

The information provided by the local distributor indicates: devices code: 55070 (standard rail length 20 cm for paediatric lrs) & 55050 (straight clamp for paediatric lrs) & 55008 (paediatric lrs c/d unit expends to 6.2 cm); batch number: unknown; quantity: 1 & 2 & 1; hospital name: (b)(6); surgeon name: dr.(b)(6); date of initial surgery: no response provided; body part to which device was applied: tibia; surgery description: lengthening; patient information: no response provided; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: the rail completely backed up and compressed while on the patient during a lengthening.While the fixator was on the patient it collapsed after and during distraction.It happened on 3 different occasions, once in the beginning while the started distraction and twice while they were out to distraction.The first time the patient had the proximal clamp tight, the distal clamp lose and the cd unit attached.The third time both clamps were tight and the cd unit was removed and it still collapsed from the patient walking.The patient had to be brought back to the or 2 times, once for an adjustment to get back to length and the last time to remove the orthofix fixator and replace it with smith & nephew fixator.The complaint report form indicates: -the device failure had adverse effects on patient; further information received from the distributor on june 5, 2017: -this complaint (b)(4) is for the same patient of (b)(4), orthofix srl (b)(4) (orthofix srl mfr report number 9680825-2017-00025 follow up 1, dated may 23, 2017).-the rail and the clamp have been shipped.The surgeon did not want to return the cd part number 55008.-the operative and x-ray images are not available.Please reference previous complaint information: -date of initial surgery: (b)(6) /2016.-patient information (age, sex and weight): (b)(6), female.-patient diagnosis: left femur lengthening.-date of the first revision surgery: (b)(6) 2017.-the orthofix fixator was removed and replaced it with smith & nephew fixator.-date of the second revision surgery (b)(6) 2017.Further information received from the distributor on june 28th, 2017: -initial surgery performed on (b)(6) 2016.Surgeon placed (1) 55070, (2) 55050 and (1) 55008 cd unit.-images taken 8 weeks' post-op revealed 55008 unit collapsed.(failed to keep the clamps in place) unsure of exact failure date.Tm stated that patient was taken in to or 2 times to bring patient back to length.Exact dates unknown.-2nd surgery performed on (b)(6) 2017 to remove the 55008.Rails and pins were not removed.New 55008 unit was placed on patient.((b)(4) mfr report number 9680825-2017-00025 follow up 1, dated may 23, 2017) -3rd surgery performed on (b)(6) 2017 to remove collapsed unit.Cd unit and rail were removed and replaced with smith & nephew.Orthofix half pins remain implanted.((b)(4) mfr report number 9680825-2017-00045, 9680825-2017-00046, mfr report 9680825-2017-00047 and mfr report 9680825-2017-00048.) manufacturer reference number: (b)(4).Distributor reference number : (b)(4).Please also kindly refer to mfr report 9680825-2017-00045 follow up 1, mfr report 9680825-2017-00046 follow up 1 and mfr report 9680825-2017-00048 follow up 1.

• Brand Name: STRAIGHT CLAMP FOR PAEDIATRIC LRS
• Type of Device: STRAIGHT CLAMP FOR PAEDIATRIC LRS
• 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: 6656119
• MDR Text Key: 78031484
• Report Number: 9680825-2017-00047
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 55050
• Device Catalogue Number: 55050
• Device Lot Number: V1429875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• 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