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

Catalog Number OE3000A/2

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 04/13/2022

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.Technical evaluation (mfr report 9680825-2022-00005).The devices involved in this event have been received by orthofix srl on may 11 and may 5.The technical evaluation on the returned devices is currently ongoing.Medical evaluation (mfr report 9680825-2022-00005).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 technical evaluation will be available.As soon as the results of the investigation will be available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

Hold kv 9/20/22 the information initially provided by local distributor indicates: product code: oe3000a/2 (quantity 2).Serial numbers: (b)(4)- (mfr reports: 9680825-2022-00005 respectively).Hospital name: (b)(6).Surgeon's name: (b)(6).Date of initial surgery: (b)(6) 2022.Body part to which device was applied: hip/femur.Surgery description: arthroplasty revision.Problem observed during: hospital pre-use inspection.Event description: "two different loan oscar systems failed the hospitals safety tests for medical equipment due to poorly fitted outer cases on the generators.An exception was made after the patient was cancelled once, and replacement system provided which had less damage than the first and then was sealed using waterproof tape.Delay in operation." the complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was not completed with the device.A replacement device of same model was not immediately available to complete surgery.The event did not lead to a delay in the duration of the surgical procedure.An additional surgery was required ((b)(6)).A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-ray images are not available.Product is available for return.Patient current health condition: recovering successfully from revision surgery.On (b)(6) 2022, orthofix srl received the following additional information from the local distributor: generators were damaged upon arrival to customer (same patient scheduled for use).(b)(6) is the date when the first surgery was planned.(b)(6) was cancelled because the generator arrived unfit for use.(b)(6) is the date when the surgery was finally performed (after the second generator "reconditioning").The adverse effects caused to this patient is the postponing of the surgery (from (b)(6)).Trauma patient, loss of theatre time and slot - deferred from (b)(6).Please also kindly refer to mfr report 9680825-2022-00005.(b)(4).

Event Description

The information initially provided by local distributor indicates: - product code: oe3000a/2 (quantity (b)(4).- serial numbers:(b)(6) and (b)(6) - (mfr reports: 9680825-2022-00005 and 9680825-2022-00006 respectively).- hospital name: (b)(6) hospital.- surgeon's name: mr (b)(6).- date of initial surgery: (b)(6) 2022.- body part to which device was applied: hip/femur.- surgery description: arthroplasty revision.- problem observed during: hospital pre-use inspection.- event description: "two different loan oscar systems failed the hospitals safety tests for medical equipment due to poorly fitted outer cases on the generators.An exception was made after the patient was cancelled once, and replacement system provided which had less damage than the first and then was sealed using waterproof tape.Delay in operation." the complaint report form also indicates: - the device failure had adverse effects on patient.- the initial surgery was not completed with the device.- a replacement device of same model was not immediately available to complete surgery.- the event did not lead to a delay in the duration of the surgical procedure - an additional surgery was required (b)(6).- a medical intervention (outpatient clinic) was not required.- copies of the operative reports are not available.- copies of the x-ray images are not available.- product is available for return.- patient current health condition: recovering successfully from revision surgery on (b)(6) 2022, orthofix srl received the following additional information from the local distributor: o generators were damaged upon arrival to customer (same patient scheduled for use) o(b)(6) is the date when the first surgery was planned o (b)(6) was cancelled because the generator arrived unfit for use o (b)(6) is the date when the surgery was finally performed (after the second generator "reconditioning") o the adverse effects caused to this patient is the postponing of the surgery (from (b)(6) to (b)(6) o trauma patient, loss of theatre time and slot - deferred from (b)(6) to (b)(6).Please also kindly refer to mfr report 9680825-2022-00005.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.Technical evaluation (mfr report 9680825-2022-00005 and 9680825-2022-00006).The returned devices, received on may 11 and may 5, 2022, were examined by orthofix srl quality operations department.The devices were subjected to visual and functional check as per orthofix specification.The visual check of both generators evidenced signs of damaging due to repeated shipments and uses.In addition the generator 2g272 evidenced a broken shoe while on the generator 2g351 was used tape to keep together the bottom and the top part of the device.The functional check of the generator 2g272 evidenced that, despite the damaging detected during the visual inspection, the device still function as expected.The functional check of the generator 2g351 evidenced that the device is not functioning properly.The case frame and the optical module are damaged.The q1, q2 and the fuse on the control board are damaged.Conclusions (mfr report 9680825-2022-00005 and 9680825-2022-00006).The technical analysis concluded that one generator (2g272) had a broken shoe but was otherwise fully functional and did not have any loose panels; the second generator (2g351) was returned with the outer panels held in position by insulating tape; this generator was non functional at the time of inspection.The failures occurred is most likely to be attributable to an accidental impact probably occurred during device handling or due to the shipping conditions of the device.Orthofix srl continues monitoring the devices on the market.

• 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
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 14423438
• MDR Text Key: 300262600
• Report Number: 9680825-2022-00006
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OE3000A/2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1