MAUDE Adverse Event Report: ORTHOFIX SRL M2 MULTIPLANAR MINIRAIL

Model Number M511

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

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 m511 lot b133 (lot laser marked on component 600523) before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation: the device concerned was received by orthofix (b)(4) on december 22, 2016.The technical evaluation on the returned device is currently on going.Medical evaluation: the information available on the case was sent to our medical evaluator.A preliminary clinical evaluation was performed and will be finalized once the results of the technical evaluation are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Evaluation in progress.

Event Description

The information provided by the local distributor indicates: hospital name: university hospital(b)(6); surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: hand; surgery description: correction; patient's information: (b)(6) years old, male; previous health condition: good.Deformity radial club hand due to radius aplasia; problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: device does not function correctly.Intraoperative use was good, however after latency days and lengthening, correction through dorso-palmar as well radio-ulnar compression screw did not function properly.Therefor correction of deformity could not be completed.The complaint report form indicates: the device failure had adverse effects on patient -loss of distraction/correction achieved; the initial surgery could be completed with device; a replacement device was not immediately available to complete surgery -patient went to other hospital for second opinion and other treatment; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required -date unknown.Patient was referred to another hospital; copy of operative reports is not available; copy of x-ray images is available; information about patient current health condition: unknown, due to patient referral to another hospital.On december 27, 2016 the distributor provided to orthofix (b)(4), a copy of x-ray images, taken before the surgery of (b)(6) 2016.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code m511 lot b133 (lot laser marked on component 600523) before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation (new information) the returned device, received on december 22, 2016 was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and functional check as per orthofix (b)(4) design and product specifications.The visual check evidenced that the component marking is quite faded but still readable.In some areas the screws seem dirty, probably corroded.The functional check was performed without loads and under loads.-the functional test performed without loads confirmed that the device functions properly: extreme positions of sliders can be reached and the device allows the rotation in two planes.-the functional test performed under loads was successful.No anomalies were detected and the device performs properly.Orthofix failure analysis can conclude that the device is still functioning properly.The failure described in the event description in using distraction-compression screws may be due to an excessive load applied on the rails.Medical evaluation: a preliminary medical evaluation was performed with the information available on the case and with the outcome of the technical analysis.Our medical evaluator will finalize the medical analysis as soon as post-operative and during correction x-rays are received.Our local distributor informed us that the hospital involved, is recording on cd the x-ray images regarding this event.Orthofix (b)(4) is expected to receive the images required in a few weeks.As soon as the results of the medical investigation are finalized orthofix (b)(4) will provide you with a follow up report.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's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: hand.Surgery description: correction.Patient's information: (b)(6), male; previous health condition: good.Deformity radial club hand due to radius aplasia.Problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: device does not function correctly.Intraoperative use was good, however after latency days and lengthening, correction through dorso-palmar as well radio-ulnar compression screw did not function properly.Therefor correction of deformity could not be completed.The complaint report form indicates: the device failure had adverse effects on patient -loss of distraction/correction achieved; the initial surgery could be completed with device; a replacement device was not immediately available to complete surgery -patient went to other hospital for second opinion and other treatment; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required -date unknown.Patient was referred to another hospital; copy of operative reports is not available; copy of x-ray images is available; information about patient current health condition: unknown, due to patient referral to another hospital.On december 27, 2016 the distributor provided to orthofix (b)(4) a copy of x-ray images, taken before the surgery of (b)(6) 2016.Further information received from the distributor on february 7, 2017: "we are waiting for the cd-rom with the x-rays, which need to be created by the hospital." (b)(4).S.

Manufacturer Narrative

Analysis of historical records (information already provided).Orthofix (b)(4) checked the internal records related to the controls made on the device code m511 lot b133 (lot laser marked on component (b)(4)) before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation (information already provided).The returned device, received on december 22, 2016 was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and functional check as per orthofix (b)(4) design and product specifications.The visual check evidenced that the component marking is quite faded but still readable.In some areas the screws seem dirty, probably corroded.The functional check was performed without loads and under loads.-the functional test performed without loads confirmed that the device functions properly: extreme positions of sliders can be reached and the device allows the rotation in two planes.-the functional test performed under loads was successful.No anomalies were detected and the device performs properly.The results of the functional test performed, both in un-loaded and loaded conditions confirmed that the device is conforming to orthofix (b)(4) specifications.Orthofix failure analysis can conclude that the device is still functioning properly.The failure described in the event description in using distraction-compression screws may be due to an excessive load applied on the rails.Medical evaluation (new information): the information available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.(b)(6) 2017 "this (b)(6) -year-old boy has complete radial aplasia with a severe valgus deformity at the wrist and shortening, and also ulnar-humeral dislocation.We really do not have enough information to understand why his treatment failed, because we only have the initial x-rays.We would need post-operative and during correction x-rays to understand what might have happened.In these cases, impingement during correction is very likely unless things are done in the right order." (b)(6) 2017 "my feeling about the failure encountered here was that it was not in distraction, but in angular correction.You have to distract first in this case to avoid impingement, but then it is necessary to make a quite large angular correction.I think that it is possible that the failure occurred in this case when they tried to make the angular correction.The exact mechanics of the correction will be different in every case, and will depend on the exact position of the hand.It would be useful to know that the angular correction facility of this fixator worked well under load.To my mind you need to distract the hand of this patient at least 25 mm before attempting any angular correction; if you do not, the carpal bones will impinge against the distal ulnar and prevent further correction.When making the correction, the soft tissue tension may be greatly increased because of the arc of correction.Because of this the distal arm of the fixator may need to be shortened to prevent excessive tension.As can be seen there are many variables in the management of each case.Unless we have the exact details what manoeuvre was being attempted it is impossible to say exactly why it failed." march 9, 2017 "the 2015 x-rays show the situation prior to intervention, as in the images already received.The 2016 images show the fixator in place and various stages of correction from (b)(6) 2016.The first image shows the proximal clamp of the fixator fully distal on the screw, and subsequent images show it moving proximally, until there were about 10 threads remaining on (b)(6).The angle between the 2 fixator arms is 55 degrees on (b)(6) and 65 degrees on (b)(6), suggesting that the angle has closed in the interval.I also noted gradually developing osteolysis round the proximal screw, becoming severe by the end of the period shown.This would have affected fixator stability.As far as can be seen in this series, the surgeons attempted to distract the proximal fixator arm initially and then correct the angulation.The image on (b)(6) appears to show some movement of the hand and carpus on to the distal ulna.However, the bones are touching, and this must imply significant soft tissue impingement which may have prevented further correction.I suspect that some angular correction was lost because of this and because of the osteolysis round one screw.If you look at the ap image of (b)(6), it is obvious that the tissues on the concave side of the deformity must be lengthened very considerably to allow for angular correction: they must be lengthened to allow correction without impingement and then lengthened some more during the correction.In this case i think that it would have been better to over-lengthen with the hand in the original position, and then shorten and make the correction at the same time, to allow correction without severe soft tissue tension.In this case i think that attempted correction resulted in the fixator being loaded beyond its design criteria because of the geometry of the frame." final comments the results of the functional test performed, confirmed that the device is conforming to orthofix (b)(4) specifications.From the results of the technical analysis it was concluded that the device is still functioning properly.The problem described in the event description in using distraction-compression screws may be due to an excessive load applied on the rails.The medical evaluation evidenced as follows: "in this case i think that attempted correction resulted in the fixator being loaded beyond its design criteria because of the geometry of the frame." based on the results of the technical evaluation that confirmed that the device is still functioning properly and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is due to the conditions of use of the device.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's name: dr.(b)(6) md; date of initial surgery: (b)(6) 2016; body part to which device was applied: hand.Surgery description: correction.Patient's information: (b)(6) years old, male; previous health condition: good.Deformity radial club hand due to radius aplasia.Problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: device does not function correctly.Intraoperative use was good, however after latency days and lengthening, correction through dorso-palmar as well radio-ulnar compression screw did not function properly.Therefore correction of deformity could not be completed.The complaint report form indicates: the device failure had adverse effects on patient -loss of distraction/correction achieved; the initial surgery could be completed with device; a replacement device was not immediately available to complete surgery -patient went to other hospital for second opinion and other treatment; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required -date unknown.Patient was referred to another hospital; copy of operative reports is not available; copy of x-ray images is available; information about patient current health condition: unknown, due to patient referral to another hospital.On december 27, 2016 the distributor provided to orthofix (b)(4) a copy of x-ray images, taken before the surgery of (b)(6) 2016.Further information received from the distributor on february 7, 2017: "we are waiting for the cd-rom with the x-rays, which need to be created by the hospital." further information received on february 16, 2017 from the distributor: in which way the device stopped working? correction of the angulation did not occur.What manoeuvre was being attempted? correction of deformity.Was the device blocked? yes; ·did the locking screw strip? not visually.Was the captive nut jammed? yes.Could the correction/adjustment actions be performed? not sufficient.We know that the little patient referred to another hospital, but when the defective device was removed, do you know if it was implanted a new device to finalize the correction or if the patient was left with no other device until another treatment was performed in another hospital? the follow-up treatment in the other hospital is unknown by the primary treating surgeon.On march 1, 2017 the distributor provided on cd a copy of pre and post op x-ray images (from (b)(6) 2015 up to (b)(6) 2016).(b)(4).

• Brand Name: M2 MULTIPLANAR MINIRAIL
• Type of Device: M2 MULTIPLANAR MINIRAIL
• 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: 6232658
• MDR Text Key: 64170998
• Report Number: 9680825-2017-00001
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M511
• Device Catalogue Number: M511
• Device Lot Number: B133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/15/2017; 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2014
• 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: 7 YR