MAUDE Adverse Event Report: ORTHOFIX SRL CEMENT REMOVAL HANDSET

Model Number	1
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4).Orthofix (b)(4) is strictly in contact with the local distributor to have the device concerned.The technical evaluation will be performed as soon as the device becomes available.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.As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report.
Event or Problem Description
The information initially provided by local distributor indicates: date of initial surgery: (b)(6) 2021.Surgery description: arthroplasty revision.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "when using oscar, the piercer went through the cement and got stuck.Surgery took three times longer than normally would have.Patient also lost more blood than expected".The complaint report form also indicated: 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 (surgery completed with osteotomes).The event led to a delay in the duration of the surgical procedure: two hours.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 may 25, 2021, orthofix (b)(4) received the following details from the sales representative: patient information (age, sex and weight) is not available.The patient is currently well.The problem seems to be with the oscar 3 generator.One of the channels appears not to be functional.(b)(4).
Additional Manufacturer Narrative
Technical evaluation.The returned oscar system, received on june 30, 2021, was examined by orthofix srl quality operation department.In particular, against this incident, the following devices were received: one ultrasonic generator code os3000 serial number (b)(4) (device originally complained); one cement removal handset code oh300/2 serial number (b)(4); one cement removal handset code oh300/2 serial number (b)(4); one cable code ch300 serial number (b)(4); one cable code ch300 serial number (b)(4).All devices were tested and found functional as expected apart from the cement removal handset code oh300/2 serial number (b)(4).The cement removal handset, device code oh300/2 serial number (b)(4), is not functioning properly.The sealing is lost from the front flange.Medical evaluation: the information made available on the event together with the results of the technical investigation were sent to our medical consultant.Please find below an extract of the medical evaluations performed."in this case a patient was having an arthroplasty revision operation.At some stage during the operation the oscar unit failed in some way, exactly how is not clear.In view of this the operation had to continue with the standard method of using manual instruments.The patient and the surgeon therefore missed the advantage of using oscar.Using manual instruments the operation will always take significantly longer and one would expect that patient to lose more blood.In this event one oscar generator, 2 handsets and 2 cables have been returned.One handset was found to be malfunctioning, batch 3h4029.The remaining components including the generator were found to be functioning normally.The malfunctioning handset was found to have a broken seal".Conclusion the results of the technical evaluation concluded that the failure found on the cement removal handset, device code oh300/2 serial number (b)(4), related to sealing lost from the front flange, is most likely to be attributable to water that entered inside the handset during cleaning and sterilization cycles as a result of normal wear and tear of silicone o-rings.Orthofix srl continues monitoring the devices on the market.
Event or Problem Description
The information initially provided by local distributor indicates: date of initial surgery: (b)(6) 2021.Surgery description: arthroplasty revision.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "when using oscar, the piercer went through the cement and got stuck.Surgery took three times longer than normally would have.Patient also lost more blood than expected".The complaint report form also indicated: 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 (surgery completed with osteotomes); the event led to a delay in the duration of the surgical procedure: two hours.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 (b)(6) 2021, orthofix srl received the following details from the sales representative: patient information (age, sex and weight) is not available; the patient is currently well; the problem seems to be with the oscar 3 generator.One of the channels appears not to be functional.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: CEMENT REMOVAL HANDSET
• Common Device Name: CEMENT REMOVAL HANDSET
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 11928087
• Report Number: 9680825-2021-00049
• Device Sequence Number: 17101531
• Product Code: JDX
• UDI-Device Identifier: 18056099649971
• UDI-Public: (01)18056099649971(11)200701(10)3G4129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1
• Device Catalogue Number: OH300/2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention