MAUDE Adverse Event Report: ORTHOFIX SRL SCREW EXTRACTOR SIZE 4 - 9 MM

Model Number 193337

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Oversedation (1990)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code (b)(4) batch g190645 before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of 33 devices.16 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 device 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.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 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 initially provided by the local distributor indicated: product code: (b)(4) (screw extractor size 4-9 mm), batch number: g190645, quantity: 1, date of surgery: (b)(6) 2020, body part to which device was applied: femur, surgery description: fracture treatment, patient's information:not applicable, problem observed during: on scheduled device removal, type of problem: device functional problem, event description: "case was for chimaera removal: we assumed the threading of the main chimaera lag screw was damaged as the normal screw driver could not engage into the thread, this probably occurred when it was inserted.The surgeon then had to revert to the screw extractor tool (193337) for removal of the main lag screw.As the extraction instrument has a reverse thread interface, engaging it into the lag screw and then also disengaging the lag screw from the nail.The problem we face is that once the screw is removed, the screw cannot be removed from the extractor tool resulting in a broken tip when we do so".The complaint report form also indicated: the device failure had adverse effects on patient (un-retrieved device fragments - the patient was in surgery for almost 3 hours and had to be rebooked and had a second operation to remove the implant).The surgery was not completed with the device.A replacement device was not immediately available to complete surgery (surgeon used easy out on removal set with components from other sets the second time) the event led to a delay in the duration of the surgical procedure (about 3 hours - patient was re-booked for surgery).An additional surgery was required (peformed on (b)(6) 2020).A medical intervention (outpatient clinic) was required ((b)(6) 2020).Copies of the operative report are not available.Copies of the x-ray images are not available.Product is available for return.Patient current health conditions: patient underwent a hip replacement surgery.Further information received from the local distributor on february 19, 2021: the patient is mid (b)(6), male and about (b)(6) kg.The nail was not removed during the first procedure and to be revised later.The nail was removed successfully during the second surgery ((b)(6) 2020).The replacement with the prosthesis was planned.The un-retrieved device fragment is from the chimaera that was broken off but was removed.X-ray images are not available.The removal tool will be send back asap.Manufacturer reference number: (b)(4).

Manufacturer Narrative

Analysis of historical records (mfr reports 9680825-2021-00012 and 9680825-2021-00050) orthofix srl checked the internal records related to the controls made on the device code 193337 batch g190645 before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of 33 devices.18 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.(mfr 9680825-2021-00012).With regards to the second screw extractor returned, only a small portion was received which do not report the batch number.Therefore, it was not possible to perform the analysis of the historical records for the specific batch.(mfr 9680825-2021-00050).Technical evaluation (mfr reports 9680825-2021-00012 and 9680825-2021-00050).The complained devices, received on march 19, 2021, were examined by orthofix srl quality operations department.In relation to this complaint, orthofix srl received: a screw extractor code 193337 batch g190645 stuck in a chimaera lag screw fixed code t93695 batch b1029951 (device initially complained; mfr report 9680825-2021-00012) a small portion of a screw extractor code 193337 stuck in a chimaera lag screw sliding code t93700 batch b1260859 (added device; mfr report 9680825-2021-00050).The returned devices were subjected to visual check as per orthofix specifications.The visual check evidenced as follows: a screw extractor code 193337 batch g190645 is stuck in a chimaera lag screw fixed code t93695 batch b1029951.The screw is visibly damaged.Several evident scratches are visible on the threaded part and on the shaft.The flaps of the screw are broken.A small portion of a screw extractor code 193337 is stuck in a chimaera lag screw sliding code t93700 batch b1260859.The screw is strongly damaged.Several evident scratches are visible on the stem.The teeth of the screw are broken.It was not possible to perform a complete dimensional and functional check as the jammed devices are damaged.The portion of the broken screw extractor was sent to an external laboratory for the raw material verification and failure investigation.The results of the technical investigation confirmed the raw material conformity to orthofix specification.The extractor broke due to bending overload.Medical evaluation (mfr reports 9680825-2021-00012 and 9680825-2021-00050) (b)(6) 2021: this patient (male, in his mid 40's and about 90 kg) had a chimaera nail inserted into a femur in the past.The plan was to remove the nail and insert a hip prosthesis.The surgeon was unable to engage the thread of the lag screw, so used the screw extractor 4 - 9 mm, code 193337.This engaged with the lag screw which was removed.By then the operation had taken 3 hours and they decided to rebook the patient for the planned prosthesis.This was carried out 3 days later.I have questions about this: why did it take so long to remove the lag screw? was the extractor tool 193337 immediately available? when the extractor was used, did it fix into the lag screw at first attempt? when the lag screw was removed, why was the nail left in situ? we assume that the nail was removed at the second surgery.How did this go? how is the patient now? march 5, 2021: the sequence of events is still a little confusing.As i understand these last comments, the first operation was performed without the orthofix extraction tool 193337.They used a synthes extraction set with various options but none of them were able to remove the lag screw.They then obtained the 193337 and were able to remove the lag screw.June 2, 2021: the technical report makes it clear that the device 193337 in question was produced originally as specified.As far as we can tell from the information provided, the chimaera lag screw was finally removed by the correct use of the screw extractor 193337, but the tip broke off when it was attempted to separate the items after removal i think that this report confirms that the screw extractor in this case functioned as specified, and broke because it was subjected to a bending load during attempted separation from the lag screw.Conclusion (mfr reports 9680825-2021-00012 and 9680825-2021-00050): the results of the technical investigation evidenced that the returned screw extractors were originally conforming to orthofix specification.In particular, in regards to the broken extractor, it was also confirmed the raw material conformity to orthofix specification.This extractor broke due to bending overload.Orthofix can assume that also the second extractor received, which was only stuck with the lag screw, would have been broken in case of an attempt in separating it from the lag screw was carried out.From the information available on the event, it is likely that the threads were damaged in the first removal attempt of the chimaera lag screw using an extraction tool from a competitor (synthes).Therefore, in the next removal surgery, the screw extractor stuck inside the lag screw due to the damaged threads.Orthofix srl would like to remind that the relevant instruction for use (pqhfn) indicates as follow: "do not use orthofix products in conjunction with those of other manufacturers, unless otherwise specified, as the combination is not covered by the necessary validation." based on the results of the technical evaluation, which confirmed the extractors conformity, and on the evidences deriving from the medical evaluation, orthofix can conclude that the problem that occurred is not device related.Orthofix srl continues monitoring the devices on the market.

Event Description

The information initially provided by the local distributor indicated: product code: 193337 (screw extractor size 4-9 mm).Batch number: g190645.Quantity: 1.Date of surgery: (b)(6) 2020.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient's information:not applicable.Problem observed during: on scheduled device removal.Type of problem: device functional problem.Event description: "case was for chimaera removal: we assumed the threading of the main chimaera lag screw was damaged as the normal screw driver could not engage into the thread, this probably occurred when it was inserted.The surgeon then had to revert to the screw extractor tool (193337) for removal of the main lag screw.As the extraction instrument has a reverse thread interface, engaging it into the lag screw and then also disengaging the lag screw from the nail.The problem we face is that once the screw is removed, the screw cannot be removed from the extractor tool resulting in a broken tip when we do so".The complaint report form also indicated: the device failure had adverse effects on patient (un-retrieved device fragments - the patient was in surgery for almost 3 hours and had to be rebooked and had a second operation to remove the implant).The surgery was not completed with the device.A replacement device was not immediately available to complete surgery (surgeon used easy out on removal set with components from other sets the second time).The event led to a delay in the duration of the surgical procedure (about 3 hours- patient was re-booked for surgery).An additional surgery was required (performed on (b)(6) 2020).A medical intervention (outpatient clinic) was required ((b)(6) 2020).Copies of the operative report are not available.Copies of the x-ray images are not available.Product is available for return.Patient current health conditions: patient underwent a hip replacement surgery.Further information received from the local distributor on february 19, 2021: the patient is mid 40's, male and about 90kg.The nail was not removed during the first procedure and to be revised later.The nail was removed successfully during the second surgery ((b)(6) 2020).The replacement with the prosthesis was planned.The un-retrieved device fragment is from the chimaera that was broken off but was removed.X-ray images are not available.The removal tool will be send back asap.Further information received from the distributor: why did it take so long to remove the lag screw? a removal set was booked with a universal nail extraction set from synthes, the lag screws threading was damaged and the lag screwdriver was not able to connect.The universal set with all its options was not suitable in assisting with the removal of that screw.Was the extractor tool 193337 immediately available? no it was not.When the extractor was used, did it fix into the lag screw at first attempt? the extractor tool during the second case fixed easily into the screw.The comment from the dr during the surgery was that the t-handle provided did not provide sufficient grip on the extractor tool after tightening it and turning in a counter clockwise direction as the handle unscrew.A solid t-handle was then used and solved the problem.Removing the screw from the extractor tool was not possible.On a previous case removing the screw, broke the tip on the removal tool (please also kindly refer to mfr report 9680825-2021-00050).When the lag screw was removed, why was the nail left in situ? the nail was removed during the second procedure after the lag screw was taken out so to continue with the hip replacement.We assume that the nail was removed at the second surgery.How did this go? as mentioned in the previous question the problem lied in the t-handle on the set and then not being able to remove the screw from the removal tool as noted in a previous removal the tip was broken when the screw was removed.How is the patient now? i was not present during the remainder of the procedure or had any contact with him afterwards.I know he was released from hospital a few days after when i spoke to the surgeon that indicated he mobilized well.Manufacturer reference number: (b)(4).Please also kindly refer to mfr report 9680825-2021-00050.

• Brand Name: SCREW EXTRACTOR SIZE 4 - 9 MM
• Type of Device: SCREW EXTRACTOR SIZE 4 - 9 MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 11364101
• MDR Text Key: 242459007
• Report Number: 9680825-2021-00012
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 18056099649216
• UDI-Public: (01)18056099649216(11)200203(10)G190645
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 193337
• Device Catalogue Number: 193337
• Device Lot Number: G190645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90