MAUDE Adverse Event Report: ORTHOFIX SRL CEMENT REMOVAL HANDSET

Catalog Number OH300/2

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Oversedation (1990)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Technical evaluation: the device involved in this event has not yet been received by orthofix srl.Orthofix srl 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 srl will provide a follow up report.

Event Description

The information provided by local distributor indicates: date of initial surgery: (b)(6) 2021.Body part to which device was applied: hip.Surgery description: arthroplasty revision.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "issues with persistent poor signal feedback on handset.Had to perform extended trochanteric osteotomy as unable to remove cement using oscar".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 saw).The event led to a delay in the duration of the surgical procedure: 1.5 hours additional surgery time.An additional surgery was 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.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

Manufacturer Narrative

Technical evaluation: the returned oscar system, received on (b)(6), 2021, was examined by orthofix quality operations department.In particular, the following devices were received: - one oscar ultrasonic generator code os3000 serial number (b)(6).- two cement removal handsets code oh300/2 serial numbers (b)(6).- one bonecutter osteotome handset code ohb300/2 serial number (b)(6).- three cables code ch300 serial numbers (b)(6).All devices were subjected to visual and functional check as per orthofix srl specification.The visual check did not evidence any anomalies.The functional check evidenced that all devices perform properly apart from the cement removal handset code oh300/2 serial number (b)(6) which is not functioning properly.The ceramics inside the device are broken.The side effect is poor feedback signal.Conclusion: the results of the technical evaluation concluded that the failure found on the cement removal handset, device code oh300/2 serial number (b)(6), is attributable to wear and tear of the ceramics inside the device.The oscar system was not properly functioning due to the damage detected on this handset.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by local distributor indicates: - date of initial surgery: (b)(6) 2021.- body part to which device was applied: hip.- surgery description: arthroplasty revision.- problem observed during: clinical use on patient/intraoperative.- type of problem: device functional problem.- event description: "issues with persistent poor signal feedback on handset.Had to perform extended trochanteric osteotomy as unable to remove cement using oscar".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 saw).- the event led to a delay in the duration of the surgical procedure: 1,5 hours additional surgery time.- an additional surgery was 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.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: CEMENT REMOVAL HANDSET
• Type of Device: CEMENT REMOVAL HANDSET
• 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: 13058361
• MDR Text Key: 288288644
• Report Number: 9680825-2021-00056
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OH300/2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Date Manufacturer Received: 01/03/2022
• 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
• Patient Outcome(s): Required Intervention