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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL GEN CASEFRAME OPTICAL 230V
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ORTHOFIX SRL GEN CASEFRAME OPTICAL 230V Back to Search Results
Model Number OE3000A/2
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  Injury  
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.Technical evaluation: the returned device received on 29th october 2020 was examined by orthofix srl quality engineering department.The technical analysis will be finalized as soon as more information regarding the description of the event is received.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.Orthofix srl has requested further information on event description, patient's details, x-ray images, patient's current health condition.Unfortunately, no more information has been received so far.As soon as the results of the investigation are available, orthofix srl will provide a follow up report.
 
Event Description
The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon's name: (b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: n/a.Surgery description: arthroplasty revision.Patient's information: n/a.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: n/a.The complaint report form also indicated: the device failure had no adverse effects on patient.The initial surgery was not completed with the device: manual instrumentation for cement extraction.The event led to a delay in the duration of the surgical procedure: 1 hour.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.No information was provided about patient current health conditions.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).
 
Event Description
The information provided by the local distributor indicates: hospital name: (b)(6).Date of initial surgery: on (b)(6) 2020.Body part to which device was applied: n/a.Surgery description: arthroplasty revision.Patient's information: n/a.Problem observed during: clinical use on patient / intraoperative.Type of problem: device functional problem.Event description: n/a.The complaint report form also indicated: the device failure had no adverse effects on patient the initial surgery was not completed with the device: manual instrumentation for cement extraction.The event led to a delay in the duration of the surgical procedure: 1 hour 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.No information was provided about patient current health conditions.Further information received on 24th november 2020 from the local distributor: "the surgeon was using the system as normal, there was a loud 'bang' and one of the modules went red and the handset no longer worked.We switched modules, but then the second module went red and no longer worked after reset.We managed to struggle on with the last module, however this was only working intermittently and resulted in the operation taking longer than expected.The hour longer was an estimation from the lead nurse who was in the operation." further information received on 16th december 2020 from the local distributor: although delayed, the surgery ended satisfactorily and the patient's health was unaffected and is well.Manufacturer reference number: 2020189.Distributor reference number: 436186.
 
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.Technical evaluation: the returned device, received on 29th october 2020, was examined by orthofix srl quality engineering department.The device was subjected to visual check as per orthofix srl specification.The visual check did not evidence any anomalies.The functional check evidenced that the generator, device code: oe3000a/2 serial number: (b)(6) is not functioning properly.The earth connection is damaged, causing a value of earth bond resistance over the maximum limit permitted by the safety test.Below are the issues found on the modules of the generator: on the digital power module: pm300 s/n: (b)(6) (channel 2), the q1, q2 and the fuse on the control board are damaged and the power board does not work properly.This causes that the module does not start.On the digital power module: pm300, s/n: (b)(6) (channel 3), the q1, q2 and the fuse on the control board are damaged and the power board does not work properly.This causes that the module does not start.Medical evaluation: there is no information at all about the mode of failure of the unit concerned.I note that the patient came to no harm and the operation was completed as anticipated.The only problem for the hospital was that the operation took one extra hour to complete.I note that the oscar generator failed to start because fuses had blown as a safety measure, because the earth connection had become faulty.This is attributed in the report to wear and tear over many uses.All other components and the handsets worked normally.Final comments: the results of the technical evaluation concluded that the failure found on the generator s/n: (b)(6), can be attributable to wear and tear of the electrical components.This can happen after multiple uses and aging of the components.Orthofix srl continues monitoring the devices on the market.
 
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Brand Name
GEN CASEFRAME OPTICAL 230V
Type of Device
GEN CASEFRAME OPTICAL 230V
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, italy 37012
IT  37012
MDR Report Key10895030
MDR Text Key218572864
Report Number9680825-2020-00059
Device Sequence Number1
Product Code JDX
Combination Product (y/n)N
PMA/PMN Number
K093805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberOE3000A/2
Device Catalogue NumberOE3000A/2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Date Manufacturer Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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