MAUDE Adverse Event Report: ORTHOFIX SRL CEMENT REMOVAL HANDSET

Model Number OH300/2

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 04/25/2018

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 returned devices, received on may 3rd, 2018, were examined by orthofix (b)(4) quality engineering department.The devices were subjected to visual and functional check as per orthofix (b)(4) specification.The visual check did not evidence any anomalies.The functional check evidenced as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly.(mfr 9680825-2018-00043).The cement removal handset, device code oh300/2 batch 3h0251, is not functioning properly.The sealing is lost from the rear body seal, therefore the handset does not work.(mfr 9680825-2018-00050).The cement removal handset, device code oh300/02 batch 3h0255, is not functioning properly.The ceramics inside are broken.The handset does not work.(mfr 9680825-2018-00051).The results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly.(mfr 9680825-2018-00043).The failure found on the cement removal handset, device code oh300/2 batch 3h0251, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles.This may happen as a result of normal wear and tear of silicone o-rings.(mfr 9680825-2018-00050).The failure found on the cement removal handset, device code oh300/2 batch 3h0255, is most likely attributable to a normal wear and tear of the internal ceramics.(mfr 9680825-2018-00051).Medical evaluation: the information made available on the case together with the results of the technical investigation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed."it seems that in this case an oscar generator was working but did not seem to be providing full power.The cause of this was not clear.As a result the operation was completed as planned but took an additional 45 minutes.I fully agree that this is a 'serious injury' and that it must be reported as you are intending".Final comments: 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.The results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly.(mfr 9680825-2018-00043).The failure found on the cement removal handset, device code oh300/2 batch 3h0251, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles.This may happen as a result of normal wear and tear of silicone o-rings.(mfr 9680825-2018-00050).The failure found on the cement removal handset, device code oh300/2 batch 3h0255, is most likely attributable to a normal wear and tear of the internal ceramics.(mfr 9680825-2018-00051).The medical evaluation confirmed that 45 minutes delay has to be considered as clinically significant.Based on the results of the technical evaluation, which confirmed the ultrasonic generator conformity, an on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is due to normal wear and tear of the handsets.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr reports 9680825-2018-00043 and 9680825-2018-00051.[(b)(4)].

Event Description

The information initially provided by the local distributor indicates: hospital name: (b)(6); surgeon name: mr (b)(6); date of surgery: (b)(6) 2018; body part to which device was applied: hip; surgery description: not applicable; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: "reported by (b)(6)- generator is not working fully, seems to work slowly and not at full power.Described by surgeon that the handset "wouldn't even heat water' loose wire perhaps?" the complaint report form also indicated: the initial surgery was completed with the device; the event led to a clinically relevant increase in the duration of the surgical procedure (extra 45 minutes); 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: no response.On may 16, 2018, orthofix (b)(4) received the revised complaint report form which included the following information: hospital name: (b)(6); surgeon name: (b)(6); date of surgery: (b)(6) 2018; body part to which device was applied: hip; surgery description: other (1st stage revision hip operation) problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: "1st stage revision hip operation reported by kelvin reed - generator is not working fully, seems to work slowly and not at full power.Described by surgeon that the handset "wouldn't even heat water' loose wire perhaps? although the module and handsets appears to synchronize independently, when the probe was placed within the femoral cavity the handsets generated no power and module frequency would not pick up".The complaint report form also indicates: 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 (extra 45 minutes); 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: no response.(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: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 7612786
• MDR Text Key: 111837477
• Report Number: 9680825-2018-00050
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OH300/2
• Device Catalogue Number: OH300/2
• Device Lot Number: 3H0251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention