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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL M2 MULTIPLANAR MINIRAIL
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ORTHOFIX SRL M2 MULTIPLANAR MINIRAIL Back to Search Results
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 v1138023 (lot marked on the component is b93) before the market release.No anomalies have been found.The original lot, manufactured in 2010, was comprised of 25 devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complant received from this specific device lot.Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4).Orthofix (b)(4)is strictly in contact with the local distributor to have the device concerned.The technical evaluation will be performed as soon as the device becomes 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 (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).
 
Event Description
The information initially provided by the local distributor indicates: - product code: m511 (m2 multiplanar minirail) - batch number: unknown - quantity: 1 - hospital name: (b)(6) hospital; - surgeon name: dr (b)(6); - date of initial surgery: (b)(6) 2018; - body part to which device was applied: no response; - surgery description: correction; - patient information: no response; - problem observed during: into treatment/post-operative; - type of problem: device functional problem; - event description: "per rep surgeon did a case in (b)(6) on a patient back in (b)(6) of this year.The patient was in (b)(6) and had an issue with something on the frame being loose.The local rep, was asked to go and look at the frame.The m511 was loose and so tm took one of the screws and tried to use that to tighten the m511 which was on the patient currently.When the patient got back to (b)(6), he went back to surgeon and they took the frame off and put on another one.The frame was replaced this past monday or tuesday.Per rep, the patient was sedated and the m511 was replaced in a procedure room".The complaint report form also indicates: the device failure did not have any adverse effects on patient; the initial surgery was completed with the device; an additional surgery was required (date of the additional surgery: (b)(6) 2018); availability of copies of the operative reports: no response; availability of copies of the x-ray images: no response; patient current health condition: no response.On nov.26.2018, orthofix (b)(4) received the following additional information together with a picture of the device: per phone conversation with the rep the lot number of the device is not known at this time.He has not picked up the device from the doctor yet.The only information i was able to gather about the patient is that he was a male.The device was placed on the forearm of the patient.The rep stated that when the patient came back from virginia and saw the doctor he removed the external frame only in a non-sterile environment and replaced it with the same device (m511).No internal pins were affected.Rep sent clinical pictures for reference.No x-rays or operative reports are available on nov.26.2018, orthofix (b)(4) received information about the batch number of the device: b93.Manufacturer reference number: (b)(4) distributor reference number : (b)(4).
 
Manufacturer Narrative
Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code m511 lot v1138023 (lot marked on the component is b93) before the market release.No anomalies have been found.The original lot, manufactured in 2010, was comprised of 25 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complant received from this specific device lot.Technical evaluation the returned device, received on (b)(6) 2018 was examined by orthofix srl quality engineering department.The device was subjected to visual and functional check as per orthofix srl specification.The visual check did not evidence any anomalies.The functional check evidenced that the device still performs properly.Medical evaluation 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) 2018: "in this case a patient (age unknown) had an m511 device applied on august 6th.A screw became loose and a local representative attempted to correct this where they were in another state.On return home the patient was seen by the physician who decided to replace the fixator under sedation.This was done on nov 5th or 6th and the patient is fine.We know no more details".- (b)(6) 2018 with the further information provided: "these images show a nicely applied m511 on the dorsal aspect of the proximal right ulna of a boy of, at a guess, 8 to 10 years.The important information about this case is that the patient was having a correction to his right ulna; the applied m511 fixator was not functioning properly and needed to be replaced for treatment to continue.This confirms our decision to classify this as a serious injury.We need that fixator to see exactly what happened".- (b)(6) 2019 with the results of the technical evaluation: "this technical report makes it very clear that this m511 fixator was functioning normally.We must therefore suggest that there was some particular factor relating to this application, but according to our investigation the fixator is completely as specified.The problem is we have so little information; clearly something went wrong, in that a screw became loose, and this was apparent to the patient or family.However we do not know which screw was affected, or why the surgeon decided to change the fixator.It will be frustrating for the surgeon and the hospital, but we can only say that we have not found anything wrong with the fixator".Final comments from the results of the technical analysis it was concluded that the returned device still performs properly and it could function as intended.The medical evaluation evidenced as follow: "the image shows a nicely applied m511 on the dorsal aspect of the proximal right ulna of a boy of, at a guess, 8 to 10 years.The important information about this case is that the patient was having a correction to his right ulna; the applied m511 fixator was not functioning properly and needed to be replaced for treatment to continue.The technical report makes it very clear that this m511 fixator was functioning normally.We must therefore suggest that there was some particular factor relating to this application, but according to our investigation the fixator is completely as specified".A complete medical evaluation of the case was not performed as some information about the medical procedure was not made available, i.E.Copies of the x-ray images.Based on the results of the technical evaluation and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem that occurred is not device related.Orthofix srl continues monitoring the devices on the market.- attachment: [2018263_fda medwatch cover letter_follow up 1.Pdf].
 
Event Description
The information initially provided by the local distributor indicates: - product code: m511 (m2 multiplanar minirail) - batch number: unknown - quantity: 1 - hospital name: (b)(6) - surgeon name: (b)(6) - date of initial surgery: (b)(6) 2018 - body part to which device was applied: no response - surgery description: correction - patient information: no response - problem observed during: into treatment/post-operative - type of problem: device functional problem - event description: "per rep surgeon did a case in philadelphia on a patient back in august of this year.The patient was in virginia and had an issue with something on the frame being loose.The local rep, was asked to go and look at the frame.The m511 was loose and so tm took one of the screws and tried to use that to tighten the m511 which was on the patient currently.When the patient got back to philadelphia, he went back to surgeon and they took the frame off and put on another one.The frame was replaced this past monday or tuesday.Per rep, the patient was sedated and the m511 was replaced in a procedure room".The complaint report form also indicates: - the device failure did not have any adverse effects on patient - the initial surgery was completed with the device - an additional surgery was required (date of the additional surgery: (b)(6) 2018 or (b)(6)2018) on (b)(6) 2018, orthofix srl received the following additional information together with a picture of the device: - per phone conversation with the rep the lot number of the device is not known at this time.He has not picked up the device from the doctor yet.The only information i was able to gather about the patient is that he was a male.The device was placed on the forearm of the patient.The rep stated that when the patient came back from virginia and saw the doctor he removed the external frame only in a non-sterile environment and replaced it with the same device (m511).No internal pins were affected.Rep sent clinical pictures for reference.- no x-rays or operative reports are available on (b)(6) 2018, orthofix srl received information about the batch number of the device: b93.Manufacturer reference number: (b)(6).Distributor reference number : (b)(6).
 
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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
MDR Report Key8145722
MDR Text Key129752170
Report Number9680825-2018-00101
Device Sequence Number1
Product Code JDW
UDI-Device Identifier18032568866544
UDI-Public(01)18032568866544(11)101124(10)V1138023
Combination Product (y/n)N
PMA/PMN Number
K955848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM511
Device Catalogue NumberM511
Device Lot NumberV1138023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Date Manufacturer Received01/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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