MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE

Model Number 99-T93790

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93790 lot b1410455 (lot b1408673 marked on component) before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4).All of them have already been distributed 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 involved in this event has not been received at orthofix (b)(4).The technical evaluation will be performed as soon as the device is returned.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 become available.As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).

Event Description

The information provided by the hospital indicates: hospital name: (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient information: (b)(6) year-old, female, weight (b)(6) kg., height 140 cm; previous health condition: good conditions.Independent.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "when inserting the cephalic screw it was not possible to screw it as it did not lock on nail.The screw was extracted and it was observed the breakage of 3 out of 6 of the teeth.Two of them have not been retrieved." the complaint report form also indicates: the device failure had no adverse effects on patient.The initial surgery was not completed with the device.A replacement device was immediately available to complete surgery.The event led to an increase in the duration of the surgical procedure of 5 minutes.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copy of operative reports is available.Copy of x-ray images is available.Patient's current health condition: good condition at discharge from hospital.Manufacturer reference number: (b)(4).

Event Description

The information provided by the hospital indicates: hospital name: (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient information: 99 year-old, female, weight 50 kg., height 140 cm; previous health condition: good conditions.Independent.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "when inserting the cephalic screw it was not possible to screw it as it did not lock on nail.The screw was extracted and it was observed the breakage of 3 out of 6 of the teeth.Two of them have not been retrieved." the complaint report form also indicates: the device failure had no adverse effects on patient.The initial surgery was not completed with the device.A replacement device was immediately available to complete surgery.The event led to an increase in the duration of the surgical procedure of 5 minutes.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copy of operative reports is available.Copy of x-ray images is available.Patient's current health condition: good condition at discharge from hospital.Manufacturer 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 99-t93790 lot b1410455 (lot b1408673 marked on component) before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 62 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical evaluation the returned device, received on may 15, 2020 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 confirmed that three out of six wings of the screw are broken.One of the broken wings was returned.The other two were probably left on patient.It was also evidenced that the teeth on the surface of the lag screw do not present contact signs that should be when the screw is locked to the nail, suggesting that the screw was not properly inserted in the nail.It is possible that an early rotation of the screw wings interfered with the hole of the nail.This can happen when the cortical hole is not adequate or if the assembly handle-nail is inadvertently rotated just before screw insertion.It is not possible to perform the functional check as the screw is damaged.The rotating part of the screw is stuck on the screw body and the sliding tip cannot slide in the tube.The device was then sent to an external laboratory for the chemical and metallographic analysis, which confirmed the conformity of the screw to material specifications.Medical evaluation the information made available on the event with the results of the technical evaluation have been sent to our medical evaluator.Please find below an extract of the medical evaluations performed.-(b)(6) 2020 in this case the surgeon inserted a neck screw for a chimaera nail.For reasons not clear the screw did not screw in properly so the surgeon removed it and inserted another, which went in as planned.This took only 5 extra minutes.The surgeon commented that 2 of the teeth did not come out with the screw.The patient is a fit 99 years and has already left hospital.I do not think that this is a serious injury.The 2 small teeth are of the same material as the large implant which will stay in this patient for the rest of her life.The operation was completed exactly as planned and the patient has been treated very well.We do not know why the screw would not go right in, but it is probably because it was slightly angled.I like the surgeon's simple and direct operating note, economic and efficient.I am inclined to suggest that this case is not reportable.If we have to report it i would suggest that it is a product malfunction, unless anything untoward turns up in the technical analysis, which is unlikely.-19 june 2020 with the results of the technical evaluation this technical analysis has confirmed that the lag screw was not originally inserted far enough to allow the teeth to engage with the nail and lock it in place.The normal deformation of the base of each tooth that occurs when the screw is fully inserted is absent.As the report says it is not possible to decide exactly why 3 of the teeth broke off, but there must have been some misalignment of the screw relative to the nail.After this lag screw was removed a second one was inserted and went in just as expected.This confirms that there were some local factors that lead to the failure of this lag screw to be inserted properly, and it is not possible to define these exactly.Suffice to say that the material of the screw is fully to specification, and the lag screw was fully checked prior to dispatch.I am inclined to agree with myself and confirm that this really does not merit reporting, as the patient was treated exactly as expected with minimal delay.Final comments the results of the technical evaluation concluded that the returned screw was originally conforming to orthofix specification.Based on the results of the technical analysis and medical evaluation, it is possible to presume that the lag screw broke due to the particular conditions of use.Orthofix can suppose that the lag screw was not inserted in the proper way and therefore was not engaged with the nail.This may have lead to the breakage of the wings.It is possible that an uneven insertion of the screw through the cortical hole, caused an early deployment of the locking mechanism.This led to an interference that deformed the wings until three of them broke.The operative technique orthofix® chimaera hip fracture system, code ref.Hf 1501 opt, shows on page 24 the instruction on how to insert the supplementary guide wire in order to avoid the rotation of nail that can happen between the step of reaming and the step of insertion of the cephalic screw.Based on the results of the technical evaluation and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the screw failed because of the particular conditions of use.Orthofix historical records show that no other notifications have been received in regards to this specific device lot.Orthofix srl continues monitoring the devices on the market.

• Brand Name: CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE
• Type of Device: CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 9805962
• MDR Text Key: 188993483
• Report Number: 9680825-2020-00026
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 18054242514749
• UDI-Public: (01)18054242514749(11)191119(17)241019(10)B1410455
• Combination Product (y/n): N
• PMA/PMN Number: K161466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99-T93790
• Device Catalogue Number: 99-T93790
• Device Lot Number: B1410455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Date Manufacturer Received: 06/16/2020
• Patient Sequence Number: 1
• Patient Age: 99 YR
• Patient Weight: 50