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 the device involved has not been received by orthofix (b)(4).Unfortunately also the lot number has not been made available, therefore it was not possible to perform the verification of the historical data.Technical evaluation: a technical analysis of the device involved in this event was not performed as the device was not returned to orthofix (b)(4) for investigation.Unfortunately, no information about lot involved is available, therefore it is not possible to perform any technical investigation.The technical evaluation of the device involved will be performed as soon as the device becomes available.(please also kindly refer to mfr report number 9680825-2016-00012 follow up 1).Medical evaluation: the little information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed: "in the recent images the timescale is not clear, but assuming that the left image is before the others, does seem that the ulna has shortened between the two images.We cannot say more about this case.However, i have said before that the use of the dorso-palmar and radio-ulnar locking screws in this fixator may not be correct in some cases, and this may result in loss of correction.It would be good to know that treatment is now continuing normally.If this is the case nothing will have been lost, although the parents and child have been put through more distress as a result of these failures.There will be no permanent damage to the child and finally the treatment wil conclude as anticipated.The device which became stiff, required replacement and we must assume that the third fixator, batch unknown, is functioning normally.So, the child and parents will have had some additional inconvenience and possibly discomfort, but the final result should be as originally anticipated.The x-rays as before are difficult to interpret, because the view is different in each image.It seems that the 3rd image, shows the hand in a better position relative to the forearm, which is the object of this treatment.Provided that the 3rd fixator is functioning normally, i do not consider that the patient has come to significant harm, beyond discomfort." as soon as the product is returned and the technical investigation is completed, the medical evaluation will be finalized according to orthofix standard practice and procedure.The distributor explained that the fixator used for the exchange is a device of regular production, duly released by orthofix (b)(4).This device was used by the distributor for demonstration purposes.Final comments: considering the lack of information provided, nor the product involved has been returned for evaluation, nor the lot number have been disclosed, it is not possible to conduct any investigation and therefore to draw any conclusion in regards to the complained device.Orthofix (b)(4) has requested further information on the event such as information on patient current health condition, lot number of the device involved and the return of the device to orthofix (b)(4) for investigation.Unfortunately, this information has not made available.In case further information is provided, or the product involved is returned, orthofix will promptly finalize the investigation on the case.Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon's name: dr.(b)(6); date of surgery: (b)(6) 2016; body part to which device was applied: hand/arm; surgery description: correction; patient's information, (b)(6), male, previous health condition: radial club hand; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: upon placement of pin/pins the surgeon discovered problems with the "gears" of the device.They did not move smoothly and he decided to not use the device.As our account manager had previously visited the surgeon showing our own demo model, the surgeon knew precisely how the fixator worked.For instruction purposes to the or nurse our demo model was left behind.And, the surgeon decided to sterilize and take our demo model for patient usage, as he would not postpone the operation of a small child.Please note that the "demo model" used is a "normal" product and as such caused no problem in usage for the surgeon.The complaint report form indicates: the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event led to a clinically relevant increase in the duration of the surgical procedure: for sterilization of the swemac osmedic owned device another 30 minutes were used.In total this exchange took approx.60 minutes of extra anaesthesia; an additional surgery was not required; copies of the operative report are available (not received); information on patient current health condition: not relevant.On february 5, 2016, orthofix (b)(4) received the following additional information from the distributor: the operation was on the (b)(6).There was adverse effects on patient: the operation/anaesthesia was prolonged for more than 60 minutes.We will try to get copy of the material (copy of operative reports and x-rays) from the hospital.The device on the patient is not a demo product and it is therefore not marked for non-patient use.On april 19, 2016, orthofix (b)(4) received the following additional information from the distributor: the fixator applied on (b)(6) 2016 worked well in the beginning of the distraction/correction period, but it "re-bound" during distraction so that the lengthening was lost.Clinically it is evaluated that length/distraction has been lost respectively the achieved correction/alignment.The fixator was then exchanged with a new fixator on (b)(6) 2016 (the x-rays are taken before the new correction and before the exchange of the m511).The fixator, which was replaced, has not yet been sent to us from the hospital - they have promised to return it asap.- copy of x-ray images.(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 b48 before the market release.No anomalies have been found.The original lot, manufactured in october 2006, was comprised of (b)(4) units.All of them have already been distributed to the market.Technical evaluation the returned device, item m511, lot b48 received on may 25, 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 aluminium part that blocks the washer of the screw used to lock one rotation movement is damaged.Therefore, that screw is not locking the rotation anymore.The functional check of the device returned did not evidence any anomalies apart from the fact that the rotation movement cannot be locked as the seat for one of the locking screws is damaged.Orthofix failure analysis concluded that the device was originally conforming to design specifications.The damage detected may be mainly attributable to incorrect use of the locking screw.(please also kindly refer to mfr report number 9680825-2016-00012 follow up 1).Final comments: the results of the technical evaluation on item m511, lot b48 evidenced that the returned device was originally conforming to design specifications.The damage detected may be mainly attributable to incorrect use of the locking screw.As a general information, orthofix (b)(4) recommends to: loosen the locking screw.Care should be taken not to loosen too much.If the locking screw is loosened too much, the nut comes out from its seat and keeps spinning without locking, thus stripping the seat of the locking screw.Correct and/or adjust.Before tightening the locking screw again, verify the position of the captive nut, which has to be in its seat.If not, the nut gets jammed.Based on the results of the technical evaluation performed on the returned device, that evidenced its conformity to orthofix (b)(4) specifications, 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: (b)(6) hospital; surgeon's name: dr.(b)(6); date of surgery: (b)(6) 2016; body part to which device was applied: hand/arm; surgery description: correction; patient's information, (b)(6), male, previous health condition: radial club hand; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: upon placement of pin/pins the surgeon discovered problems with the "gears" of the device.They did not move smoothly and he decided to not use the device.As our account manager had previously visited the surgeon showing our own demo model, the surgeon knew precisely how the fixator worked.For instruction purposes to the or nurse our demo model was left behind.And, the surgeon decided to sterilize and take our demo model for patient usage, as he would not postpone the operation of a small child.Please note that the "demo model" used is a "normal" product and as such caused no problem in usage for the surgeon.The complaint report form indicates: the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event led to a clinically relevant increase in the duration of the surgical procedure: for sterilization of the swemac osmedic owned device another 30 minutes were used.In total this exchange took approx.60 minutes of extra anaesthesia; an additional surgery was not required; copies of the operative report are available (not received); information on patient current health condition: not relevant.On february 5, 2016, orthofix (b)(4) received the following additional information from the distributor: the operation was on the (b)(6).There was adverse effects on patient: the operation/anaesthesia was prolonged for more than 60 minutes.We will try to get copy of the material (copy of operative reports and x-rays) from the hospital.The device on the patient is not a demo product and it is therefore not marked for non-patient use.On april 19, 2016, orthofix (b)(4) received the following additional information from the distributor: the fixator applied on (b)(6) 2016 worked well in the beginning of the distraction/correction period, but it "re-bound" during distraction so that the lengthening was lost.Clinically it is evaluated that length/distraction has been lost respectively the achieved correction/alignment.The fixator was then exchanged with a new fixator on (b)(6) 2016 (the attached x-rays are taken before the new correction and before the exchange of the m511).The fixator, which was replaced, has not yet been sent to us from the hospital - they have promised to return it asap.Copy of x-ray images.The distributor explained that the fixator used for the exchange is a device of regular production, duly released by orthofix (b)(4).This device was used by the distributor for demonstration purposes.On may 25, 2016, orthofix (b)(4) received from the distributor, the return of the fixator involved in this event.Updated information on analysis of historical records and outcome of the technical evaluation is included.(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: 5658802
• MDR Text Key: 45293446
• Report Number: 9680825-2016-00045
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 07/04/2016

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: B48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2006
• 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: 4 YR