MAUDE Adverse Event Report: ORTHOFIX SRL GEN CASEFRAME NON OPTICAL 115V

Model Number OE3000B/1

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Oversedation (1990)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

On july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix (b)(4) is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.The devices involved in this event were manufactured by orthosonics ltd.Technical evaluation: the devices involved in this event have not been returned to orthofix (b)(4).As soon as the devices are received, orthofix (b)(4) will perform the technical analysis.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 technical evaluation and/or further information are available.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.Please kindly refer also to mfr report number 9680825-2018-00093.

Event Description

The information initially provided by the local distributor indicates: hospital name: university (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2018.Body part to which device was applied: hip.Surgery description: unavailable.Patient information: (b)(6), male.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: per the tm, during a case on (b)(6) 2018 at univ.(b)(6) with dr.(b)(6), the probe ohp2080su (lot number wo/19982/a) would not tune to frequency.They needed to have the ultrasonic wave to be transferred through probe and would not work.The generator, (lot 384) that they were using would not work.The case was delayed by 2 to three hours, 2 of the 3 modules would not work.The doctor would try to remove cement.Sometimes it would work for 10-11 seconds or 10 minutes then would stop.They would have to it turn off and on the generator and eventually would work but only intermittently.Towards the end of the surgery, it did start to work.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 clinically relevant increase in the duration of the surgical procedure: 2 to 3 hours delay.An additional surgery was not required; a medical intervention (outpatient clinic) was not required; copies of the operative report are not available; copies of the x-ray images are not available; patient current health conditions: unknown.(b)(4).

Event Description

The information initially provided by the local distributor indicates: hospital name: (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery:(b)(6) 2018.Body part to which device was applied: hip.Surgery description: unavailable.Patient information: (b)(6), male.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: per the tm, during a case on (b)(6) 2018 at(b)(6) hsp with dr.(b)(6), the probe ohp2080su (lot number wo/19982/a) would not tune to frequency.They needed to have the ultrasonic wave to be transferred through probe and would not work.The generator, (lot 384) that they were using would not work.The case way delayed by 2 to three hours, 2 of the 3 modules would not work.The doctor would try to remove cement.Sometimes it would work for 1011 seconds or 10 minutes then would stop.They would have to it turn off and on the generator and eventually would work but only intermittently.Towards the end of the surgery, it did start to work.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 clinically relevant increase in the duration of the surgical procedure: 2 to 3 hours delay.An additional surgery was not required; a medical intervention (outpatient clinic) was not required; copies of the operative report are not available; copies of the xray images are not available; patient current health conditions: unknown manufacturer reference number: (b)(4).Distributor reference number: (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.Devices involved in this event were manufactured by orthosonics ltd.Technical evaluation: a technical evaluation of the devices involved was not possible as they were not returned to orthofix srl.Medical evaluation: the information made available on the case was sent to our medical evaluator.Please see below an extract of the medical evaluation performed: in this case a hip revision was being carried out and the oscar equipment seemed only to work intermittently with long delays.As a result the operation was delayed for 2 - 3 hours, and because of this is defined as a serious injury and is reportable.As far as we know the operation was completed as planned and the patient is fine.I cannot comment on the details because we have no more information.However, i do say that i am not sure how hospitals expect to carry out these operations without a backup system.This is a serious injury primarily because of the delay.Final comments: a technical evaluation of the devices involved was not possible as they were not returned to orthofix srl.Based on the information available on the event, it was not possible to finalize the investigation and determine the root cause of the event notified.Orthofix srl historical records show that no other similar notifications have been received in regards to these specific device lots.In case further information is received or the devices involved are returned, orthofix srl will promptly re-open the issue and finalize the investigation.Orthofix srl continues monitoring the devices on the market.(please kindly refer also to mfr report number 9680825-2018-00093 follow up 1) - attachment: [(b)(4)_fda medwatch cover letter follow up 1.Pdf].

Event Description

The information initially provided by the local distributor indicates: - hospital name: (b)(6); - surgeon name: dr.(b)(6); - date of initial surgery: (b)(6) 2018.- body part to which device was applied: hip; - surgery description: unavailable; - patient information: m.E.M, male; - problem observed during: clinical use on patient/intraoperative - type of problem: device functional problem.- event description: per the tm, during a case on (b)(6) 2018 at univ.Of connecticut hsp with dr.(b)(6), the probe ohp2080su (lot number wo/19982/a) would not tune to frequency.They needed to have the ultraonsic wave to be transferred through probe and would not work.The generator, (lot 384) that they were using would not work.The case was delayed by 2 to three hours, 2 of the 3 modules would not work.The doctor would try to remove cement.Sometimes it would work for 10-11 seconds or 10 minutes then would stop.They would have to it turn off and on the generator and eventually would work but only intermittently.Towards the end of the surgery, it did start to work.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 clinically relevant increase in the duration of the surgical procedure: 2 to 3 hours delay; - an additional surgery was not required; - a medical intervention (outpatient clinic) was not required; - copies of the operative report are not available; - copies of the x-ray images are not available; - patient current health conditions: unknown.Further information captured from the complaint form included in the box of the returned generator, received on may 10, 2019: -(b)(6) had to "play" with the generator and handsets; -the event led to a clinically relevant increase in the duration of the surgical procedure: slightly: hip revision add 40 minutes.Manufacturer reference number: (b)(4).Distributor reference number: (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.Devices involved in this event were manufactured by orthosonics ltd.Technical evaluation (new information) the returned device, received on may 10th, 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 oe3000b/1 serial number (b)(6) is not functioning properly.On the digital power module pm300 s/n (b)(6) the display is out of order and the electrical components driving the output frequency are not functioning properly.A technical evaluation of the piercer probe involved was not possible as it was not returned to orthofix srl.Medical evaluation (revised information) the information made available on the case was sent to our medical evaluator.Please see below an extract of the medical evaluation performed: in this case a hip revision was being carried out and the oscar equipment seemed only to work intermittently with long delays.As a result the operation was delayed for 2 - 3 hours, and because of this is defined as a serious injury and is reportable.As far as we know the operation was completed as planned and the patient is fine.I cannot comment on the details because we have no more information.However, i do say that i am not sure how hospitals expect to carry out these operations without a backup system.This is a serious injury primarily because of the delay.I also note that the display unit and the electronic components driving it had failed.The failure is suggested to be caused by rough handling and possibly wear and tear.The revised report form suggests that the additional time required was about 40 minutes.I agree with you that this is better for the patient than the originally suggested extra time of more than 2 hours.Final comments (revised information) the failure found on the o2 generator s/n (b)(6), is most likely attributable to an accidental impact as bumps, vibrations or hard shocks.This may happen during an incorrect device handling during the normal use or during transport, i.E.Without the correct carry case or without the correct placement inside the carry case.A technical evaluation of the piercer probe involved was not possible as it was not returned to orthofix srl.Orthofix srl historical records show that no other similar notifications have been received in regards to these specific device lots.Orthofix srl continues monitoring the devices on the market.(please kindly refer also to mfr report number 9680825-2018-00093 follow up 1) - attachment: [2018227_fda medwatch cover letter follow up 2.Pdf].

• Brand Name: GEN CASEFRAME NON OPTICAL 115V
• Type of Device: GEN CASEFRAME NON OPTICAL 115V
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 8013252
• MDR Text Key: 125276339
• Report Number: 9680825-2018-00092
• 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,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OE3000B/1
• Device Catalogue Number: OE3000B/1
• Device Lot Number: 2G384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention