MAUDE Adverse Event Report: GENESYS SPINE SACROILIAC JOINT FUSION SYSTEM

Model Number	1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant emailed photos of a damaged si driver to genesys spine.Genesys spine received communication from complainant that the threaded tip of the inner shaft of the driver broke off in the head of the si screw.The threaded tip of the si driver was left in the si screw that was implanted in the patient.
Additional Manufacturer Narrative
Device or other product related factors (i.E design, qc, labeling) possibly contributing to the health hazard: based on a review of the drawing and the dhr, the instrument was manufactured to specifications using surgical grade stainless steel (17-4 stainless steel per astm f8999) hardened to h900.No anomalies were found during review of the manufacturing records.Evaluation of the fracture surface on the returned instrument showed that the inner shaft failed as a result of torsional stress on a hardened material.This is consistent with the expected use of the instrument (the inner shaft is threaded in & out of the si screws) and also consistent with 17-4 stainless steel hardened to h900 (slightly brittle material).The fracture surface showed two distinct fracture planes formed prior to ultimate failure.The orientation of the fracture planes shows the fractures formed during tightening of the instrument into the screw.More specifically, the fracture surface showed that a crack formed at the edge of a thread when the shaft was being used to tighten the instrument into a screw but the device didn't fail (initially).Multiple extreme force tightening attempts of the inner shaft propagated the crack further ultimately resulting in the failure of the shaft.Based on this analysis, the person tightening the si screws onto the driver applied excessively high twisting force (torsion) when tightening the driver onto a screw.Instrument should have been inspected for signs of damage during cleaning and sterilization prior to use.17-4 stainless steel hardened to h900 is used in applications requiring high strength and toughness.It's an excellent material for high stress medical applications such as the threaded inner shaft on this instrument.In addition, the glp159 helios lumbar plate drivers have been in the field since september of 2020 and this is the first reported incident of the tip of the shaft breaking.The design is considered sound and the materials are appropriate for all intended uses.The extension of the threaded inner shaft from the instrument's tip is a critical feature controlled on the drawing and inspected at receiving inspection.Use related, user, or human performance contributing factors: the si screws require small instruments (to fit the small size of the screws) to withstand relatively high loads.Many surgeons apply very high tightening torques to the si screws to ensure that the si screws are as tight as possible to the si joint.Evaluation of the returned device showed that extremely high forces (torque) were applied to the inner shaft of the driver while tightening the instrument to a si screw.Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.Conclusions: based on this analysis, the person tightening the si screws onto the driver applied excessively high twisting force (torsion) when tightening the driver onto a screw.Instrument should have been inspected for signs of damage during cleaning and sterilization prior to use.Genesys spine ifus specify that instruments are to be inspected for damage and wear after cleaning and sterilization.If damage or wear is noted that may compromise the proper function of the instrument, the distributor or user should contact their genesys spine field services manager for a replacement (ifu-022 genesys spine sacroiliac joint fusion system ifu).Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.
Additional Manufacturer Narrative
Device or other product related factors (i.E design, qc, labeling) possibly contributing to the health hazard: based on review of the drawing and the dhr, the instrument was manufactured to specifications using surgical grade stainless steel (17-4 stainless steel per astm f8999) hardened to h900.No anomalies were found during review of the manufacturing records.Evaluation of the returned instrument shows a failure of the threaded tip of the inner shaft.This failure is consistent with the expected use of the instrument (the inner shaft is threaded in and out of the si screws).After reviewing the fracture surface (image 1) on the returned instrument, the orientation of the fracture planes and grain closely align to a bending moment induced fracture with hints of torsional strain which is evident in the intended and expected use of the instrument.Without the secondary piece of the failed instrument, the broken tip, it is difficult to ascertain the exact method of failure.Based on this analysis, the high likelihood of failure was due to the individual who was using the instrument, applying both an excessive amount of torsional force along with introducing bending moments (most likely due to navigating the instrument into the correct position) when tightening the driver onto the screw.The instrument should have been inspected for signs of damage during cleaning and sterilization prior to use.17-4 stainless steel hardened to h900 is used in applications requiring high strength and toughness.It is an excellent material for high stress medical applications such as the thread for the inner shaft on this instrument.In addition, the gsi203 si screw drivers have been in continuous use since may of 2018, and this is the first reported incident of the tip of the driver shaft failing.The design is considered sound and the materials appropriate for the intended use.The extension of the threaded inner shaft from the instrument's tip is a critical feature controlled on the drawing and inspected when received in and prior to shipping out.Use related, user, or human performance contributing factors: the si screws require small instruments (to fit the small size of the screws) to withstand relatively high loads.Many surgeons apply very high tightening torques to the si screws to ensure that the si screws are as tight as possible to the si joint.Evaluation of the returned device showed that extremely high forces (torque) were applied to the inner shaft of the driver while tightening the instrument to a si screw.Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.Conclusions: based on this analysis, the person tightening the si screws onto the driver applied excessively high twisting force (torsion) when tightening the driver onto a screw.Instrument should have been inspected for signs of damage during cleaning and sterilization prior to use.Genesys spine ifus specify that instruments are to be inspected for damage and wear after cleaning and sterilization.If damage or wear is noted that may compromise the proper function of the instrument, the distributor or user should contact their genesys spine field services manager for a replacement (ifu-022 genesys spine sacroiliac joint fusion system ifu).Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.Mdr correction: event type changed from adverse event to malfunction.
Event or Problem Description
The complainant emailed photos of a damaged si driver to genesys spine.Genesys spine received communication from complainant that the threaded tip of the inner shaft of the driver broke off in the head of the si screw.The threaded tip of the si driver was left in the si screw that was implanted in the patient.
Additional Manufacturer Narrative
Device or other product related factors (i.E design, qc, labeling) possibly contributing to the health hazard: based on review of the drawing and the dhr, the instrument was manufactured to specifications using surgical grade stainless steel (17-4 stainless steel per astm f8999) hardened to h900.No anomalies were found during review of the manufacturing records.Evaluation of the returned instrument shows a failure of the threaded tip of the inner shaft.This failure is consistent with the expected use of the instrument (the inner shaft is threaded in and out of the si screws).After reviewing the fracture surface (image 1) on the returned instrument, the orientation of the fracture planes and grain closely align to a bending moment induced fracture with hints of torsional strain which is evident in the intended and expected use of the instrument.Without the secondary piece of the failed instrument, the broken tip, it is difficult to ascertain the exact method of failure.Based on this analysis, the high likelihood of failure was due to the individual who was using the instrument, applying both an excessive amount of torsional force along with introducing bending moments (most likely due to navigating the instrument into the correct position) when attempting to implant the si screw.The instrument should have been inspected for signs of damage during cleaning and sterilization prior to use.17-4 stainless steel hardened to h900 is used in applications requiring high strength and toughness.It is an excellent material for high stress medical applications such as the thread for the inner shaft on this instrument.In addition, the gsi203 si screw drivers have been in continuous use since may of 2018, and this is the first reported incident of the tip of the driver shaft failing.The design is considered sound and the materials appropriate for the intended use.The extension of the threaded inner shaft from the instrument's tip is a critical feature controlled on the drawing and inspected when received in and prior to shipping out.Use related, user, or human performance contributing factors: the si screws require small instruments (to fit the small size of the screws) to withstand relatively high loads.Surgeons may have applied both an excessive amount of torsional force along with introducing bending moments when attempting to navigate the si screw into the appropriate location of the si joint.Evaluation of the returned device showed that bending movement were applied to the inner shaft of the driver while navigating the si screw into the si joint.Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.Conclusions: based on this analysis, the surgeon appears to have applied both an excessive amount of torsional force along with introducing bending moments while attempting to navigate the si screw into the si joint.Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.Since the broken tip of the si driver was left threaded in the si screw within the surgical site, event was reported under mdr.
Event or Problem Description
The complainant emailed photos of a damaged si driver to genesys spine.Genesys spine received communication from complainant that the threaded tip of the inner shaft of the driver broke off in the head of the si screw.The threaded tip of the si driver was left in the si screw that was implanted in the patient.
Event or Problem Description
The complainant emailed photos of a damaged si driver to genesys spine.Genesys spine received communication from complainant that the threaded tip of the inner shaft of the driver broke off in the head of the si screw.The threaded tip of the si driver was left in the si screw that was implanted in the patient.
Additional Manufacturer Narrative
Device or other product related factors (i.E design, qc, labeling) possibly contributing to the health hazard: based on review of the drawing and the dhr, the instrument was manufactured to specifications using surgical grade stainless steel (17-4 stainless steel per astm f8999) hardened to h900.No anomalies were found during review of the manufacturing records.Evaluation of the returned instrument shows a failure of the threaded tip of the inner shaft.This failure is consistent with the expected use of the instrument (the inner shaft is threaded in and out of the si screws).After reviewing the fracture surface (image 1) on the returned instrument, the orientation of the fracture planes and grain closely align to a bending moment induced fracture with hints of torsional strain which is evident in the intended and expected use of the instrument.Without the secondary piece of the failed instrument, the broken tip, it is difficult to ascertain the exact method of failure.Based on this analysis, the high likelihood of failure was due to the individual who was using the instrument, applying both an excessive amount of torsional force along with introducing bending moments (most likely due to navigating the instrument into the correct position) when tightening the driver onto the screw.The instrument should have been inspected for signs of damage during cleaning and sterilization prior to use.17-4 stainless steel hardened to h900 is used in applications requiring high strength and toughness.It is an excellent material for high stress medical applications such as the thread for the inner shaft on this instrument.In addition, the glp159 helios lumbar plate drivers have been in continuous use since (b)(6) 2020, and this is the first reported incident of the tip of the driver shaft failing.The design is considered sound and the materials appropriate for the intended use.The extension of the threaded inner shaft from the instrument's tip is a critical feature controlled on the drawing and inspected when received in and prior to shipping out.Use related, user, or human performance contributing factors: the si screws require small instruments (to fit the small size of the screws) to withstand relatively high loads.Many surgeons apply very high tightening torques to the si screws to ensure that the si screws are as tight as possible to the si joint.Evaluation of the returned device showed that extremely high forces (torque) were applied to the inner shaft of the driver while tightening the instrument to a si screw.Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.Conclusions: based on this analysis, the person tightening the si screws onto the driver applied excessively high twisting force (torsion) when tightening the driver onto a screw.Instrument should have been inspected for signs of damage during cleaning and sterilization prior to use.Genesys spine ifus specify that instruments are to be inspected for damage and wear after cleaning and sterilization.If damage or wear is noted that may compromise the proper function of the instrument, the distributor or user should contact their genesys spine field services manager for a replacement (ifu-022 genesys spine sacroiliac joint fusion system ifu).Regardless, the manner in which the device was used is in-line with the intended use and this failure will be recorded as device malfunction.Mdr correction: event type changed from adverse event to malfunction.

• Brand Name: SACROILIAC JOINT FUSION SYSTEM
• Common Device Name: SACROILIAC JOINT FUSION
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx hwy; bldg 3, ste 600; austin 78746
• Manufacturer Contact: raquel brown ; 1250 s. capital of tx hwy; bldg 3, ste 600; austin 78746 ; 5123817070
• MDR Report Key: 17311230
• Report Number: 3008455034-2023-00010
• Device Sequence Number: 17768773
• Product Code: OUR
• UDI-Device Identifier: M719GSI2030
• UDI-Public: +M719GSI2030/$$7LK20200902R
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1
• Device Catalogue Number: GSI203
• Device Lot Number: 7LK20200902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 06/12/2023; 06/12/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 07/25/2023; 07/25/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown