MAUDE Adverse Event Report: ORTHOFIX SRL G-BEAM STAINLESS STEEL FUSION BEAM L110MM D7.4MM STERILE

Model Number 99-877110

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: it was not possible to identify the code reference of the screw involved as it was received contaminated at orthofix (b)(4).The device returned is undergoing the necessary cleaning and decontamination activities, after which it will be possible to identify the code reference of the screw.Orthofix (b)(4) checked the internal records related to the controls made on the g-beam stainless steel fusion beam sterile, before the market release.No anomalies have been found.According to orthofix (b)(4) historical records, this is the first notification received on a g-beam stainless steel fusion beam sterile.Technical evaluation: the technical evaluation of the device involved, received on april 1, 2019 is currently on going.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.The patient involved in this event is the same patient involved in a previous event, orthofix (b)(4) ref: (b)(4), notified to fda on march 28, 2019, mfr report number 9680825-2019-00022.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.(b)(4).

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6), surgeon's name: dr.(b)(6), date of removal surgery: (b)(6) 2019, body part to which device was applied: foot right, patient information: female, type of problem: functional problem.Event description: implant extraction from initial charcot treatment.The g-beam implant was removed from the patient.The device moved during treatment.Dr.(b)(6) removed one gbeam 7.4mm stainless steel fusion beam without any trouble.The patient involved in this event is the same patient involved in a previous event, orthofix (b)(4) ref: (b)(4), notified to fda on march 28, 2019, mfr report number 9680825-2019-00022.The complaint report form also indicates: the device failure had adverse effects on patient; the initial surgery was completed with the device; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required: performed on (b)(6) 2019; a medical intervention (outpatient clinic) was not required; copies of the operative report are not available; copies of the x-ray images are available; information about patient current health condition is not available.(b)(4).

Event Description

The information provided by the local distributor indicates: - hospital name: (b)(6) - surgeon's name: (b)(6) - date of removal surgery: (b)(6) 2019 - body part to which device was applied: foot right - surgery description: n/a - patient information: female - problem observed during: n/a - type of problem: functional problem - event description: implant extraction from initial charcot treatment.The g-beam implant was removed from the patient.The device moved during treatment.Dr.Bourgault removed one gbeam 7.4mm stainless steel fusion beam without any trouble.The patient involved in this event is the same patient involved in a previous event, orthofix srl ref: 2019043, notified to fda on (b)(6)2019, mfr report number 9680825-2019-00022.The complaint report form also indicates: - the device failure had adverse effects on patient - the initial surgery was completed with the device - the event did not lead to a clinically relevant increase in the duration of the surgical procedure - an additional surgery was required: performed on (b)(6) 2019 - a medical intervention (outpatient clinic) was not required - copies of the operative report are not available - copies of the x-ray images are available - information about patient current health condition is not available further information received on 2nd may 2019: - screw is reference 99-877110 lot b1224079 - the other implant was left as initially without any other treatment - patient reveals in normal state manufacturer reference number: (b)(4).Distributor reference number: 69 please refer also to mfr report number 9680825-2019-00037.

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 99-877110 batch b1224079 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 85 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first notification received from this specific device code and lot.Traceability of specific lot of the end cap code 99-870010 is not possible as the information is not marked on the product.According to orthofix srl historical records, this is the first notification received from this specific device code.Technical evaluation on (b)(6) 2019 orthofix srl received 1 g-beam stainless steel fusion beam l110mm d7.4mm sterile code 99-877110 lot b1224079 and 1 g-beam stainless steel end cap high compression sterile code 99-870010 lot not laser marked on end cap.The visual check did not evidence any anomalies on the screw surface, whereas there is a gap between the end cap and the screw.Moreover, the threads of the end cap are damaged.This damage probably occurred during removal of the screw.The dimensional check of the screw and of the end cap did not show any anomalies.The functional check was not performed because it was not possible to remove the end cap from the screw without damaging the internal thread.The raw material check confirms the conformity of screw and end cap to orthofix specifications.Medical evaluation the information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluations: (b)(6) 2019 the antecedent events to this case occurred on (b)(6) and were reported on (b)(6).One of the two hex screwdrivers necessary for g-beam insertion was missing from the tray and the surgeon improvised using an osteotome to turn the implant in.It seems that this was not a successful improvisation, because within a short time (the skin sutures were still in place from the surgery) the distal end of the 1st metatarsal implant was extruded and appeared at the end of the dorsal foot wound.The wound in the sole of the foot looks swollen as though there is a haematoma there.It was necessary to remove the implant.It seems likely that the second implant remains in situ; we are not told definitely.It is very likely that this happened because the surgeon was unable to insert the implant correctly because he lacked the correct instrument.(b)(6) 2019 with the outcome of the technical analysis this technical analysis confirms that the g beam and end cap were fully to specification.The end cap was not inserted fully into the beam because an improvised screwdriver was being used.It seems that the patient is well.They have not stated whether the desired arthrodesis has been achieved.Conclusions as before.Final comments the results of the technical investigation evidenced that the returned devices (screw and end cap) were originally conforming to design specifications.The functional check was not performed as it was not possible to remove the end cap from the screw without damaging the internal thread.Based on the results of the technical evaluation performed on the returned devices, and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem occurred is related to the conditions of use of the devices, following the lack of the necessary instrumentation during the initial surgery performed on (b)(6) 2019.(note: the patient involved in this event is the same patient involved in a previous event, orthofix srl ref: 2019043, notified to fda on (b)(6) 2019, mfr report number 9680825-2019-00022) orthofix srl historical records show that no other similar notifications have been received in regards to these specific device codes.Orthofix srl continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2019-00037 - attachment: [2019071_fda medwatch cover letter follow up 1.Pdf].

• Brand Name: G-BEAM STAINLESS STEEL FUSION BEAM L110MM D7.4MM STERILE
• Type of Device: G-BEAM STAINLESS STEEL FUSION BEAM L110MM D7.4MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 8521918
• MDR Text Key: 142230486
• Report Number: 9680825-2019-00024
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K172698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 99-877110
• Device Catalogue Number: 99-877110
• Device Lot Number: B1224079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention