MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS SUPPLEMENTARY LAG SCREW L105MM STERILE

Model Number	99-T93505
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93505 lot v1431683 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93705 lot v1431059 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the devices involved in this event have not yet been received by orthofix (b)(4).The technical evaluation will be performed as soon as the devices 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 become 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.Please kindly refer also to mfr report number 9680825-2019-00039.(b)(4).
Event or Problem Description
The information provided by the hospital involved and the sales manager indicates: hospital name: (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2019.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient information: female, (b)(6).Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "during the engagement phase of the main sliding screw it stopped without engaging properly and it was not possible to remove it.The same happened with the supplementary lag screw".The complaint report form also indicates: the device failure had adverse effects on patient: loss of fracture reduction; the initial surgery was completed with the devices; the event led to a clinically relevant increase in the duration of the surgical; procedure: delay in surgery and cut out; patient's x-ray images are available.Manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 99-t93505 lot v1431683 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Orthofix srl checked the internal records related to the controls made on the device code 99-t93705 lot v1431059 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the devices involved in this event have not been received by orthofix srl as they are on patient.The technical evaluation will be performed as soon as the devices becomes available.Medical evaluation: the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluations: on (b)(6) 2019: in this case it is reported that the two chimaera lag screws failed to engage with the nail and could not be removed.It is reported that the two lag screws failed because they cut out.The x-rays show an initial film taken on (b)(6) 2019, the day after the original operation on (b)(6) 2019.This shows clearly that neither of the lag screws are inserted properly.They have both been inserted too superiorly, and are not engaged with the femoral neck.The next oblique film of (b)(6) 2019 shows the lag screws seemingly to be completely outside the femoral neck and head.The ap views following are very similar to the initial one on (b)(6) 2019; the oblique view is from a different angle but the ap views are similar.These suggest that the screws have not moved since insertion, and were not inserted correctly in the first place.The fracture was not reduced properly and the screws were not inserted into the femoral head.They did not cut out: they were never in the correct position.The patient requires a second operation.However, there is no evidence that the device directly contributed to this event; the operation was not carried out correctly as described, because the reduction was not correct, and the lag screws were not inserted correctly.It is impossible to say whether they are engaged with the nail or not, but the prime cause of this event was a technical matter related to this operation, not the device.(b)(6) 2019 with the further information provided whether or not the lag screws were fully engaged with the nail, the prime cause of the problems in this case are that the original reduction was poor and the lag screws were not inserted correctly in the centre of the femoral neck.We do not have a complete sequence of the x-rays, but we can see that the original fixation, dated (b)(6) 2019, shows that the main lag screw is very short and close to the superior surface of the femoral neck; the supplementary lag screw seems to have penetrated the side of the femoral neck, and is outside the bone.The x-ray of (b)(6) 2019 shows that both screws are outside the femoral head.This may be an oblique view; it is certainly a different projection to the march film.The other x-rays are undated, so their sequence is uncertain.The extra time involved has not been quantified so we cannot comment on that.I confirm my original thoughts that the problems with this case are entirely technical and are nothing to do with the system used for fixation.A prime requirement in these fractures is that they are reduced correctly.Sometimes this is not easy, but it has not been done in this case.I cannot see that this fracture will unite; a non union if highly likely.Final comments: the devices involved in this event have not been received by orthofix srl as they are on patient.Therefore, it was not possible to perform the technical analysis.Based on the investigation performed on the event description and x-ray it is possible to conclude that the problem is due to the conditions of use of the devices, i.E.To an incorrect positioning of the screws with respect to the femoral head.The operative technique orthofix® chimaera hip fracture system, code ref.(b)(4), reports on page 20 the instructions on the positioning of the proximal locking screws: "the nail is inserted through the entry point to a desired depth (fig.19a).Attention should be paid to the position of the lag screw which should be in the center of the femoral neck and head.If the supplementary lag screw is used, the lag screw could be below the center of the femoral neck and head.This is especially important in patients with a narrow femoral neck.If necessary, the impaction rod can be connected on top of the targeting handle and tightened by using the 6mm hex screwdriver for hammering with the slotted mallet (fig.19b).The condition of the medial/anterior cortex must be always checked prior to hammering." based on the investigation performed on the event description and x-ray it is possible to conclude that the problem occurred is due to the application conditions of the devices.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix srl continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2019-00039 follow up 1 - attachment: [2019098_fda medwatch cover letter follow up 1.Pdf].
Event or Problem Description
The information provided by the hospital involved and the sales manager indicates: hospital name: (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery: on (b)(6) 2019.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient information: female, 81 year-old.Problem observed during: clinical use on patient / intraoperative.Type of problem: device functional problem event description: "during the engagement phase of the main sliding screw it stopped without engaging properly and it was not possible to remove it.The same happened with the supplementary lag screw".The complaint report form also indicates: the device failure had adverse effects on patient: loss of fracture reduction.The initial surgery was completed with the devices.The event led to a clinically relevant increase in the duration of the surgical procedure: delay in surgery and cut out.Patient's x-ray images are available.Further information received on june 7, 2019: the screw did not engage correctly with the nail.It is not possible to quantify the surgery extra time, but i believe it was a delay of a few minutes.Patient's details and patient's current health condition are not available.A new surgery is not planned so far.Manufacturer reference number: (b)(4).

• Brand Name: CHIMAERA HFS SUPPLEMENTARY LAG SCREW L105MM STERILE
• Common Device Name: CHIMAERA HFS SUPPLEMENTARY LAG SCREW L105MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 8666649
• Report Number: 9680825-2019-00038
• Device Sequence Number: 16721530
• Product Code: HSB
• UDI-Device Identifier: 18054242515098
• UDI-Public: (01)18054242515098(11)160625(17)210525(10)V1431683
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2021
• Device Model Number: 99-T93505
• Device Catalogue Number: 99-T93505
• Device Lot Number: V1431683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR