MAUDE Adverse Event Report: ORTHOFIX SRL OSTEOTITE BONE SCREW 200/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM

Model Number 99-SS60627

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code (b)(4) batch b1752654 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of 60 devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received from this specific device lot.Technical evaluation: the stem of the bone screw involved in this event has not yet been received by orthofix srl.Orthofix srl 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.Orthofix srl has requested further information on the event such as name of the surgeon, date of the initial surgery, patient information (age, sex, weight), patient current state of health, copies of the x-ray images, picture of the frame/fixator and device availability for the analysis.Unfortunately, this information has not yet made available.As soon as the results of the investigation are available, orthofix srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by local distributor indicates: product code: 99-ss60627.Batch number: b1752654.Hospital name: (b)(6).Body part to which device was applied: tibia.Surgery description: fracture treatment.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "bone screw got broken when installing an external fixator.The part could not be extracted from left tibia of the patient".The complaint report form also indicates: the device failure had adverse effects on patient (un-retrieved device fragments).The initial surgery was not completed with the device.A replacement device of same model was immediately available to complete surgery.Product is available for return.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: 99-ss60627, batch: b1752654 (lot market on the component is g210041) before the market release.No anomalies have been found.The original lot, manufactured in 2021, 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 from this specific device lot.Technical evaluation: the returned portion of the broken screw, received on august 18, 2022, was examined by orthofix srl quality operations department.The returned portion of the bone screw was subjected to visual and dimensional check as per orthofix srl specification.The visual check confirmed the problem notified, the screw is broken in correspondence of the threaded portion.It was also evidenced presence of several scratches on the stem of the screw.The dimensional check, performed where possible, did not evidence any anomalies.A functional check on the returned screw was not possible as the device is broken and therefore not functioning.It was also performed the documental check of the raw material certificate.No issues were found.From the results of the technical evaluation, it was confirmed the device conformity to design specification.The screw failed due to torsional overload.Medical evaluation: the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."in this case a 200/30 osteotite bone screw, thread diameter 4.5 - 3.5 mm.Was being used for fixation in a young person's tibia (details not supplied), to provide fixation for a circular frame.Using the screw shaft as reference it can be seen that the bone diameter at this point is 20-21 mm.3 bone screws with thread diameter 4.5 - 3.5 mm have been used in the distal clamp, and one larger diameter threaded screw in the proximal metaphysis.Of the 3 distal screws inserted, one additional screw fragment can be seen, and the most distal screw does not seem to have been inserted past the first cortex, which has been fragmented during screw insertion.It seems that a drill bit may not have been used, certainly for the most distal screw, as there is no drill track in the second cortex.The last image shows that the screw fragment broke off at the surface of the first cortex.Comment: we know from long experience that there is a great risk of screw breakage when a 4.5 - 3.5 mm diameter threaded screw is inserted into a bone more than 18 mm in diameter.I can see why a narrow thread was chosen here, because the bone is small, but a 5 - 6 mm threaded screw should have been used.In addition there is a puzzle about the lack of a drill track for one of the bone screws.The surgeon would have been advised to use a drill bit of correct diameter, in this case 3.2 mm, and drill both cortices, passing the drill bit twice through the bone to be sure.It should have then been possible to insert the bone screw with care, applying only a low torque, and only by hand, not with a powered instrument.It is clear from the technical report and from the x-ray appearance that this screw broke during insertion because of excessive torque, probably because of a failure to prepare the insertion track correctly.The technical report confirms that the screw material was as specification.We know that screw breakage is very uncommon, and nearly always happens because of a failure to follow the correct insertion technique with a screw of correct diameter for the bone dimensions".Conclusion: the results of the technical evaluation evidenced that the returned screw was conforming to design specification.The screw failed due to torsional overload.According to the information provided on the case and as a result of the investigation performed, orthofix srl can conclude that the screw was subjected to torsional overload during insertion which caused it to break.The breakage is related to the inadequate screw size selected.The breakage is therefore not device related.Orthofix srl would like to remind the importance of meticulously following the instructions for use (ref.To pqscr), where detailed information are reported regarding screw selection and the correct insertion technique.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by local distributor indicates: product code: 99-ss60627, batch numebr: b1752654, hospital name: (b)(6).Body part to which device was applied: tibia.Surgery description: fracture treatment.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "bone screw got broken when installing an external fixator.The part could not be extracted from left tibia of the patient".The complaint report form also indicates: the device failure had adverse effects on patient (un-retrieved device fragments).The initial surgery was not completed with the device.A replacement device of same model was immediately available to complete surgery.Product is available for return.On (b)(6) 2022, orthofix srl received the following additional details and some x-ray images: name of the surgeon: dr.(b)(6).The patient is 18 years old date of the initial surgery: on (b)(6) 2022.The event did not lead to a delay in the surgical time.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-ray images are available.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: OSTEOTITE BONE SCREW 200/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM
• Type of Device: OSTEOTITE BONE SCREW 200/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 15063451
• MDR Text Key: 304715712
• Report Number: 9680825-2022-00013
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 18032568039306
• UDI-Public: (01)18032568039306(11)211110(17)261010(10)B1752654
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99-SS60627
• Device Catalogue Number: 99-SS60627
• Device Lot Number: B1752654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18 YR