MAUDE Adverse Event Report: ORTHOFIX SRL ULTRASONIC GENERATOR 230V CE

Model Number 1

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records (mfr report 9680825-2021-00022).Orthofix (b)(4) checked the internal records related to the controls made on the piercer probe code (b)(4) batch b1387807 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device code.Technical evaluation (mfr reports 9680825-2021-00022).The technical evaluation on the returned generator, received on march 10, 2021, is currently on going.The broken probe was discarded by the hospital and therefore is not available for the investigation (mfr report 9680825-2021-00022).Medical evaluation (mfr reports 9680825-2021-00022).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.Orthofix (b)(4) has requested also copies of the x-ray images.Unfortunately, the x-rays has not yet made available.As soon as the results of the investigation ongoing on the returned generator are available, orthofix (b)(4) will provide a follow up report.

Event Description

The information initially provided by local distributor indicates: date of initial surgery: (b)(6) 2021.Surgery description: arthroplasty revision.Patient's information: (b)(6) years, male, in good health condition.Type of problem: device functional problem.Event description: "repetition of an error message "poor signal"; difficulty to progress with the cimented probes; broken probe".The complaint report form also indicated: the device failure did not have any adverse effects on patient.The initial surgery was completed with the device.The event led to a delay in the duration of the surgical procedure: 1 hour total delay; wrong road in the femur.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copy of operative reports and x-ray images are not available.Product is available for return.On march 22, 2021, orthofix (b)(4) received the following details from the sales representative: "the complaint is related to an oscar generator code os3000 serial number (b)(4) and one piercer probe code ohp2062su batch b1387807 (mfr report 9680825-2021-00022).During surgery, the probe did not recognize the bone which was pierced.The probe is not returning (lost by the hospital) while the generator is on the way back to orthofix (b)(4)".On march 25, 2021, orthofix (b)(4) received the following details from the sales representative: the surgery was completed using the standard hand instruments.They went out of the distal femur.The patient is fine.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).Please also kindly refer to mfr report 9680825-2021-00022.

Event Description

The information initially provided by local distributor indicates: - date of initial surgery: (b)(6) 2021.- surgery description: arthroplasty revision.- patient's information: 68 years, male, in good health condition.- type of problem: device functional problem.- event description: "repetition of an error message "poor signal"; difficulty to progress with the cemented probes; broken probe".The complaint report form also indicated: - the device failure did not have any adverse effects on patient.- the initial surgery was completed with the device.- the event led to a delay in the duration of the surgical procedure: 1 hour total delay; wrong road in the femur.- an additional surgery was not required.- a medical intervention (outpatient clinic) was not required.- copy of operative reports and x-ray images are not available.- product is available for return.On march 22, 2021, orthofix srl received the following details from the sales representative: "the complaint is related to an oscar generator code os3000, serial number (b)(6) (mfr report 9680825-2021-00021) and one piercer probe code ohp2062su batch b1387807 (mfr report 9680825-2021-00022).During surgery, the probe did not recognize the bone which was pierced.The probe is not returning (lost by the hospital) while the generator is on the way back to orthofix srl".On march 25, 2021, orthofix srl received the following details from the sales representative: - the surgery was completed using the standard hand instruments.- they went out of the distal femur.- the patient is fine.On april 12, 2021, orthofix srl received the following details from the sales representative: despite several reminders, i do not receive the x ray images.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).Please also kindly refer to mfr reports 9680825-2021-00022 and 9680825-2021-00026.

Manufacturer Narrative

Analysis of historical records (mfr report 9680825-2021-00022).Orthofix srl checked the internal records related to the controls made on the piercer probe code ohp2062su batch b1387807 before the market release.No anomalies have been found.The original lot, manufactured in 2019, 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 in regards to this specific device code.Technical evaluation (mfr reports 9680825-2021-00021 and 9680825-2021-00022 and 9680825-2021-00026).The returned oscar system, received on march 10, 2021, was examined by orthofix srl quality operations department.All components of the returned oscar system, were subjected to visual and functional check as per orthofix srl specification.The visual check did not evidence any anomalies.The functional check evidenced as follows: 1.The ultrasonic generator, device code os3000 serial number (b)(6), is functioning as expected (mfr report 9680825-2021-00021).2.The bonecutter osteotome handset, device code ohb300/2 serial number (b)(6), is not functioning properly (mfr report 9680825-2021-00026).A technical evaluation of the broken piercer probe was not possible as the probe was discarded by the hospital and therefore not available for the investigation (mfr report 9680825-2021-00022).Medical evaluation (mfr reports 9680825-2021-00021 and 9680825-2021-00022 and 9680825-2021-00026).The information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."we do not have complete information here, but on what we have so far we can say: male patient 68 years having an arthroplasty revision using oscar 3.There was an undefined problem with the equipment that resulted in an error message on screen.After this they had some problems using the cement removing handsets.We have been told that this operation was completed with hand instruments.We now understand that a hole was made in the distal femur, either by a hand instrument or the probe, probably by the probe.We don't know exactly how this happened but the incident was being blamed on the oscar system.The patient will have come to no harm and the operation was completed as planned".Conclusion (mfr reports 9680825-2021-00021 and 9680825-2021-00022 and 9680825-2021-00026) the functional check evidenced as follows: 1.The ultrasonic generator, device code os3000 serial number (b)(6), is functioning as expected (mfr report 9680825-2021-00021) 2.The bonecutter osteotome handset, device code ohb300/2 serial number (b)(6), is not functioning properly (mfr report 9680825-2021-00026).A technical evaluation of the broken piercer probe was not possible as the probe was discarded by the hospital and therefore not available for the investigation (mfr report 9680825-2021-00022).A complete medical evaluation was not possible as the x-ray images have not been made available.Orthofix can assume that the problem occurred during surgery is attributable to the failure detected on the bonecutter osteotome handset.Orthofix srl continues monitoring the devices on the market.

• Brand Name: ULTRASONIC GENERATOR 230V CE
• Type of Device: ULTRASONIC GENERATOR 230V CE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 11594066
• MDR Text Key: 260764388
• Report Number: 9680825-2021-00021
• Device Sequence Number: 1
• Product Code: JDX
• UDI-Device Identifier: 18056099649971
• UDI-Public: (01)18056099649971(11)200701(10)3G4129
• Combination Product (y/n): N
• PMA/PMN Number: K093805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1
• Device Catalogue Number: OS3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR