MAUDE Adverse Event Report: ORTHOFIX SRL GEN CASEFRAME OPTICAL 230V

Model Number OE3000A/2

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Code Available (3191)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

On july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.The device involved in this event was manufactured by orthosonics ltd.This event was initially evaluated as a not reportable event.Following further information received on june 18, 2019 (longer surgery time with anaesthesia), the event was re-evaluated and classified as a reportable event.Technical evaluation the device concerned has not been received at orthofix srl yet.The technical evaluation will be performed as soon the device is received.Medical evaluation the information 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

On (b)(6) 2019, the information initially provided by the local distributor indicates: (b)(6)."recently returned to hospital on (b)(6) 2019 following servicing.Power enters machine and power light visible, when handsets plugged in lcd not displaying.All handset checked with all cables." on 18 june 2019 the local distributor provided the complaint form completed with the following further details: hospital name: (b)(6).Surgeon name: (b)(6).Date of initial surgery: reported (b)(6) 2019.Body part to which device was applied: not able to use.Surgery description: arthroplasty revision (hip).Patient information: (b)(6) year-old, male.Problem observed during: n/a.Type of problem: n/a.Event description: power enters machine and power light visible, when handsets plugged in lcd not displaying.All handset checked with all cables.The complaint report form also indicated: the device failure had adverse effects on patient: longer surgical time and patient under anaesthetic.The initial surgery was not completed with the device.A replacement device was not immediately available to complete surgery: long cement instruments were used to complete surgery.The event led to a clinically relevant increase in the duration of the surgical procedure: longer surgical time and patient under anaesthetic (extra time needed not specified).An additional surgery was not required: this is first stage revision.A medical intervention (outpatient clinic) was not required.Patient current health conditions: no response.(b)(4).

Manufacturer Narrative

On july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.The device involved in this event was manufactured by orthosonics ltd.This event was initially evaluated as a not reportable event.Following further information received on june 18, 2019 (longer surgery time with anaesthesia), the event was re-evaluated and classified as a reportable event.Technical evaluation: the returned device, received on 15th july 2019, was examined by orthofix srl quality engineering department.The device was subjected to visual and functional check as per orthofix srl specification.The visual check did not evidence any anomalies.The functional check evidenced that the ultrasonic generator, device code oe3000a/2 serial number (b)(4) is not functioning properly.The rear panel socket is damaged.All generator modules do not work when activated.Medical evaluation: the information made available on the case together with the results of the technical investigation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed.On (b)(6) 2019: in this case a 79 year old patient was having a first hip prosthesis revision, using the oscar system for cement removal.The oscar system malfunctions and the operation was completed with manual instruments.As far as we know the patient is well and the hip revision was completed satisfactorily.The operation took longer to complete than anticipated with the oscar system, but this is not specified.I do not consider that the malfunction of the oscar system might have caused a serious deterioration in health.The surgeon should always, as was the case here, be able to complete the operation without the oscar system, by using manual instruments.The patient is in the middle of the operation, and the technical equipment that is used to speed up cement removal is not working.The surgeon uses manual instruments and the operation is completed satisfactorily.The surgeon carried out the cement removal with no problems using hand instruments.This was a procedure planned and agreed to prior to the surgery; the technical details varied according to local circumstances.30 july with the outcome of the technical analysis this technical analysis has revealed that the rear mains input socket was damaged in such a way that the current was not transmitted to the rest of the system.The cause was probably incorrect handling of the device at some stage.It seems to me that this should have been obvious from the beginning and should have been discovered before the operation was begun.I am sure that each oscar generator should be tested as far as possible before the operation is begun.No change in reporting.My comments previously still hold.Final comments: the results of the technical evaluation concluded that the damages of the generator are attributable to an accidental impact as bumps, vibrations or hard shocks.This may happen during an incorrect device handling during the transport without the suitable carry case.The medical evaluation evidenced as follows: in this case a 79 year old patient was having a first hip prosthesis revision, using the oscar system for cement removal.The oscar system malfunctions and the operation was completed with manual instruments.As far as we know the patient is well and the hip revision was completed satisfactorily.The patient is in the middle of the operation, and the technical equipment that is used to speed up cement removal is not working.The surgeon uses manual instruments and the operation is completed satisfactorily.This technical analysis has revealed that the rear mains input socket was damaged in such a way that the current was not transmitted to the rest of the system.The cause was probably incorrect handling of the device at some stage.Based on the results of the technical evaluation and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem that occurred is due to incorrect device handling during use and/or shipping.Orthofix srl continues monitoring the devices on the market.

Event Description

On 16 april 2019, the information initially provided by the local distributor indicates: (b)(6) faulty generator 2g127 "recently returned to hospital on (b)(6) 2019 following servicing.Power enters machine and power light visible, when handsets plugged in lcd not displaying.All handset checked with all cables." on 18 june 2019 the local distributor provided the complaint form completed with the following further details: hospital name: (b)(6) hospital.Surgeon name: mr.(b)(6).Date of initial surgery: reported (b)(6) 2019.Body part to which device was applied: not able to use.Surgery description: arthroplasty revision (hip).Patient information: 79 yearold, male.Problem observed during: n/a.Type of problem: n/a.Event description: power enters machine and power light visible, when handsets plugged in lcd not displaying.All handset checked with all cables.The complaint report form also indicated: the device failure had adverse effects on patient: longer surgical time and patient under anaesthetic.The initial surgery was not completed with the device.A replacement device was not immediately available to complete surgery: long cement instruments were used to complete surgery.The event led to a clinically relevant increase in the duration of the surgical procedure: longer surgical time and patient under anaesthetic (extra time needed not specified).An additional surgery was not required: this is first stage revision.A medical intervention (outpatient clinic) was not required.Patient current health conditions: no response.Further information provided by the local distributor on 17th july 2019: date of initial surgery: (b)(6) 2019.Weight and height of patient: not available.Problem observed during clinical use on patient.Extra time needed to finalize the surgery: 3040 minutes.The surgery was completed manually.Copy of xray images: no access.Patient's current health condition: not available.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: GEN CASEFRAME OPTICAL 230V
• Type of Device: GEN CASEFRAME OPTICAL 230V
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 8763996
• MDR Text Key: 208120341
• Report Number: 9680825-2019-00045
• Device Sequence Number: 1
• Product Code: JDX
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OE3000A/2
• Device Catalogue Number: OE3000A/2
• Device Lot Number: 2G127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR