| Model Number 54-11230 |
| Device Problem
Mechanical Problem (1384)
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| Patient Problem
Device Embedded In Tissue or Plaque (3165)
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| Event Date 03/30/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Analysis of historical records: the devices involved in this event were discarded by the hospital.Unfortunately also the lot numbers have not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: a technical evaluation of the devices involved was not possible, as the devices were discarded by the hospital (apart from the tip of the device code 54-11230 which was left in the patient).Medical evaluation: the few information made available on the event was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once further details become available.Orthofix (b)(4) requested further information on the event such as: batch number of the two screws involved, date of the initial surgery, date of the screws breakage, site of application, age, sex and weight of the patient, patient diagnosis and proposed treatment, date of the frame removal, correction planned and correction achieved before devices failure, as the frame was removed at the doctor's office, which system is currently in use by patient? copies of the pre and post-operative x-ray images, patient current health conditions, unfortunately, this information has not yet made available.As soon as further information is received, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2019-00030.
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Event Description
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The information provided by the local distributor indicates: products code: 54-11230 /tl+ half pin ao 4mm x 180mm) and 54-11240 (tl+ half pin ao 5mm x 180mm) - mfr reports 9680825-2019-00029 and 9680825-2019-00030 respectively.Batchs number: unknown.Quantity: 1 each.Hospital name: (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery: unknown.Body part to which device was applied: unknown.Surgery description: correction.Patient information: unknown.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: about 2 ½ weeks after patient surgery with dr.(b)(6), patient was weight bearing as the patient had a rocker rail attached to frame and half pins 54-11230 and 54-11240 sheared.Per the rep ((b)(6)), he states that dr.(b)(6) feels like the frame may have been a little loose, creating enough pressure to shear the pins.The 5mm broke just below ½ cm from fixation bolt, the 4mm was below and broke at the skin.Per the rep, part of the 4mm pin was left in the patient.Dr.(b)(6) removed the frame.Further information: no product will be returning as part of half pins were discarded and the remainder of devices remains implanted (part of the 4mm half pin was left in the patient).The complaint report form also indicates: the device failure had adverse effects on patient (un-retrieved device fragments).The initial surgery was completed with device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required (territory manager states that an additional surgery will be done in the future).A medical intervention was required (performed to remove the frame, date of the removal is unknown).Availability of copies of the operative reports: no response.Availability of copies of the x-rays images:no response.Patient current health condition: no response.(b)(4).
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Manufacturer Narrative
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Analysis of historical records the devices involved in this event were discarded by the hospital.Unfortunately also the lot numbers have not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation a technical evaluation of the devices involved was not possible, as the devices were discarded by the hospital (apart from the tip of the device code 54-11230 which was left in the patient).Medical evaluation the information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluation performed.- april 16, 2019 with the initial information: "we have very little information on this case.A surgeon applied a truelok frame on the leg, completing it with a rocker frame for weightbearing.We do not know the type of frame, the intended treatment or the diagnosis.2.5 weeks later two screws broke.A 4 mm screw broke close to the skin and has been left in situ (it must have broken at the junction with the bone); a 5 mm screw broke close to the fixation bolt and was removed completely by the surgeon in his office with the rest of the frame.Thus treatment had to be stopped because of the breakages, and further surgery is planned.The broken parts of the screws were discarded".- may 17, 2019 with the further information received on may 15: "we now have a lot of information about this incident.In summary: - march 7, 2019: first x-ray after sustaining pilon fracture which occurred after a fall on ice while inebriated - march 10, 2019: initial operation for a comminuted pilon fracture in a female patient of 56 years who is a heavy smoker and an alcoholic, and vitamin d deficient.Truelok frame applied with rocker for ambulation.- march 21, 2019: patient returned to operating room because of infected tensioned wire which was treated and wire removed.- march 30, 2019: 2 half pins were found to be broken; external fixation removed and cast applied.The pins were one 4 mm and one 5 mm.- april 25, 2019: patient still in a cast; some callus formation is observed.This patient was treated with great care but her lifestyle made it very difficult to fix this severe fracture successfully.Because of her frequent state of inebriation from alcohol or drugs, the loading on the two bone screws from weightbearing would have been more than their design criteria.I suggest that in this type of patient more robust fixation elements should have been used (6 mm diameter bone screws) and it might have been better not to place a rocker because this invites weightbearing.However, this is a counsel of perfection and it is highly probable that it was impossible to treat this fracture ideally in this patient.Half pin breakage in the orthofix system is very rare and nearly always is attributable to the use of too small a diameter implant".Final comments a technical evaluation of the devices involved was not possible, as the devices were discarded by the hospital (apart from the tip of the device code 54-11230 which was left in the patient).The technical evaluation will be performed should the devices become available.The medical evaluation evidenced as follows: "this patient was treated with great care but her lifestyle made it very difficult to fix this severe fracture successfully.Because of her frequent state of inebriation from alcohol or drugs, the loading on the two bone screws from weightbearing would have been more than their design criteria.I suggest that in this type of patient more robust fixation elements should have been used (6 mm diameter bone screws) and it might have been better not to place a rocker because this invites weightbearing.However, this is a counsel of perfection and it is highly probable that it was impossible to treat this fracture ideally in this patient.Half pin breakage in the orthofix system is very rare and nearly always is attributable to the use of too small a diameter implant".Considering the information provided, it was not possible to surely determine the root cause of the breakages occurred.Should the devices involved become available, orthofix srl will finalize the investigation.Orthofix srl continues monitoring the devices on the market.Please also kinldy refer to mfr report 9680825-2019-00030.- attachment: [2019078_fda medwatch cover letter_follow up 1.Pdf].
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Event Description
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The information initially provided by the local distributor indicates: - products code: 54-11230 (tl+ half pin ao 4mm x 180mm) and 54-11240 (tl+ half pin ao 5mm x 180mm) - mfr reports 9680825-2019-00029 and 9680825-2019-00030 respectively - batch number: unknown - quantity: 1 each - hospital name: williamsport - surgeon name: dr.Ritter - date of initial surgery: unknown - body part to which device was applied: unknown - surgery description: correction - patient information: unknown - problem observed during: into treatment/post-operative - type of problem: device functional problem - event description: about 2 ½ weeks after patient surgery with dr.Ritter, patient was weight bearing as the patient had a rocker rail attached to frame and half pins 54-11230 and 54-11240 sheared.Per the rep (josh day), he states that dr.Ritter feels like the frame may have been a little loose, creating enough pressure to shear the pins.The 5mm broke just below ½ cm from fixation bolt, the 4mm was below and broke at the skin.Per the rep, part of the 4mm pin was left in the patient.Dr.Ritter removed the frame.- further information: no product will be returning as part of half pins were discarded and the remainder of devices remains implanted (part of the 4mm half pin was left in the patient).The complaint report form also indicates: - the device failure had adverse effects on patient (un-retrieved device fragments) - the initial surgery was completed with device - the event did not lead to a clinically relevant increase in the duration of the surgical procedure - an additional surgery was required (territory manager states that an additional surgery will be done in the future) - a medical intervention was required (performed to remove the frame, date of the removal is unknown) - availability of copies of the operative reports: no response - availability of copies of the x-rays images: no response - patient current health condition: no response on may 15th, 2019, orthofix srl received copy of the operative reports and the following additional information included in a revised complaint report form: - date of initial surgery: 3/10/2019 - body part to which device was applied: left leg - surgery description: fracture treatment - patient information: pl, 56 years, 70 kg, pilon fracture - additional information received: the initial date of surgery was 3/10/2019.The patient diagnosis and proposed treatment was pilon fracture / exfix.On 3/21/2019 patient was put under mild sedation for infected wire in left foot external fixation device.The date of the pin breakages was 3/30/2019.The follow up visits occurred weekly since 3/10 and the frame was removed on 3/30.Correction planned and correction achieved before device failure - exfix stabilization and fixation.The lot number of the 54-11230 and the lot number of the 54-11240 were not provided/unknown.The patient is stable and is in a cast.X-ray findings and operative reports have been provided.- date of the additional surgery: 3/30/2019 - a medical intervention (outpatient clinic) was not required - copies of the x-ray images are not available: x-ray findings were provided - products not available for return - patient is stable manufacturer reference number: 2019078 distributor reference number: fc 276295.
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