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

Model Number 99-T93790

Device Problem Break (1069)

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 99-t93790 lot v1431055 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 released 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 was received at orthofix (b)(4) on (b)(6) 2018.The technical evaluation is ongoing.Medical evaluation: the information made 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 investigation are available.As soon as further information on the case is 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 provided by the local distributor indicates: hospital name: (b)(6); surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2018; body part to which device was applied: n/a; surgery description: fracture treatment; patient information: n/a; problem observed during: into treatment/post-operative; event description: femoral neck was not properly reduced and fixed in a neck angle greater than what is recommended.The main lag screw broke as per attached pictures.Nail was extracted, and chimaera was used for re fixation.The initial procedure was done at (b)(6) hospital.The 2nd procedure was done at (b)(6) on (b)(6) 2018 the complaint report form also indicates: the device failure had adverse effects on patient: loss of fracture reduction and loss of achieved correction.The initial surgery was completed with the device.An additional surgery was required following device failure: performed on (b)(6) 2018.Copies of the operative reports are not available copies of the x-ray images are available.Patient current health condition: n/a.On (b)(6) 2018, orthofix (b)(4) received copy of x-ray images and the following further information: "please find attached form and x-rays in connection with a broken lag screw with chimaera nail.The surgeon whom initially performed surgery struggled to reduce the neck angle sufficiently.On the x-rays you can see a broken k-wire in an attempt to reduce femoral neck angle.The femoral neck was fixed in an angle greater than what is described as normal parameters.The patient presented with a broken lag screw to (b)(6) approximately 9 months after initial surgery." on (b)(6) 2018, orthofix (b)(4) received the following further information: "the patient is being followed up as an outpatient through clinic, i have requested information from dr and awaiting his response." 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 99t93790 lot v1431055 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 released to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical evaluation: the following items were received on december 5th 2018: 99t93790 chimaera hfs lag screw sliding l90mm sterile, t93130 short nail 130°, t93785 sliding lag screw 85 mm, t931030 locking screw 30 mm.Only the broken chimaera hfs lag screw sliding l90mm sterile, code reference (b)(4) was examined by orthofix srl quality engineering dept, as the other items of the implant did not show any anomalies.The device was subjected to visual and dimensional check as per orthofix srl design and product specifications.The visual check confirmed that the lag screw sliding is damaged.The screw is broken in proximity of the conical part.The dimensional check performed where possible did not evidence any anomalies.It was not possible to perform the functional check as the device is broken.Medical evaluation: the information made available on the case with the outcome of the technical analysis was sent to our medical evaluator.Please find below an extract of the medical evaluation performed.On (b)(6) 2018: this was a basal neck fracture of the right femur which was fixed originally at (b)(6) hospital, south africa on (b)(6) 2018.The xrays show very clearly that the fracture was not reduced.It was fixed with a chimaera nail with a single 90 mm sliding cephalic screw, in the unreduced position.I do not think that the fractured surfaces are in contact, and there has been no sign of union in the last 11 months.There is also the broken piece of a k wire which was used to try to improve the reduction.The cephalic screw has broken in 2 places, and the fixation has completely collapsed.The patient was reoperated on at (b)(6) hospital, and the surgeon has done a good job.This time the fracture position looks good and the fixation with another chimaera nail and 2 cephalic screws seems excellent.The distal screw is in the dynamic slot in the static position.I would have thought that it would have been better with dynamic distal locking.However, the fracture should now heal.The femoral head shows no sign of avascular necrosis.The first fixation broke because of the lack of reduction.This was a non union, which is to be expected in these fractures if the fracture is not reduced correctly.The screw broke because of fatigue failure because of loading beyond its design criteria.On 4 february 2019 with the results of the technical analysis.So, this patient was of average dimensions even if we do not have the exact details.The technical analysis confirms the breakages visible on the xrays.It does look as though the cephalic screw underwent fatigue failure to about half of its diameter, and then broke due to overload, which was inevitable.The technical analysis also confirms that the material was to specification.I agree that the cause of the breakage was fatigue failure secondary to excess loading of the implant because of fracture non union, which occurred because the fracture was not adequately reduced.Final comments: the results of the technical evaluation evidenced that the device was originally conforming to orthofix srl design specifications.We can assume that the screw broke due to the incorrect application that led to nonunion.The medical evaluation evidenced as follows: "i agree that the cause of the breakage was fatigue failure secondary to excess loading of the implant because of fracture non union, which occurred because the fracture was not adequately reduced." based on the information available on the event, and on the analysis performed on the xray images received it is possible to reasonably suppose that the failure occurred due to incorrect application (fracture not well reduced led to breakage and nonunion).Orthofix srl 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.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon's name: (b)(6).Date of initial surgery: (b)(6) 2018.Body part to which device was applied: n/a.Surgery description: fracture treatment.Patient information: n/a.Problem observed during: into treatment/postoperative: event description: femoral neck was not properly reduced and fixed in a neck angle greater than what is recommended.The main lag screw broke as per attached pictures.Nail was extracted, and chimaera was used for re fixation.The initial procedure was done at (b)(6) hospital.The 2nd procedure was done at (b)(6) 2018.The complaint report form also indicates: the device failure had adverse effects on patient: loss of fracture reduction and loss of achieved correction the initial surgery was completed with the device an additional surgery was required following device failure: performed on (b)(6) 2018 copies of the operative reports are not available, copies of the xray images are available, patient current health condition: n/a.On november 15 2018, orthofix srl received copy of xray images and the following further information: "please find attached form and xrays in connection with a broken lag screw with chimaera nail.The surgeon whom initially performed surgery struggled to reduce the neck angle sufficiently.On the xrays you can see a broken kwire in an attempt to reduce femoral neck angle.The femoral neck was fixed in an angle greater than what is described as normal parameters.The patient presented with a broken lag screw to (b)(6) approximately 9 months after initial surgery." on (b)(6) 2018, orthofix srl received the following further information: "the patient is being followed up as an outpatient through clinic, i have requested information from dr and awaiting his response." on (b)(6) 2019, orthofix srl received the following further information: "the patient never returned for follow up appointments.And the dr is not sure if he will return again.If it helps at all i estimate the patient to be about 1,8 meters tall and his weight is approximately 7080 kilograms." manufacturer reference number: (b)(4).

• 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, italy 37012 ; IT 37012
• MDR Report Key: 8145793
• MDR Text Key: 129751925
• Report Number: 9680825-2018-00103
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 18054242514749
• UDI-Public: (01)18054242514749(11)160620(17)210520(10)V1431055
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: 99-T93790
• Device Catalogue Number: 99-T93790
• Device Lot Number: V1431055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 01/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention