MAUDE Adverse Event Report: ORTHOFIX SRL BONECUTTER OSTEOTOME HANDSET

Model Number OHB300/2

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

In 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.(item involved in this event was manufactured by orthosonics ltd).Technical evaluation: the device involved in this event was received by orthofix (b)(4) on november 21, 2018.The technical evaluation is ongoing.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 technical evaluation become available.As soon as the results of the investigation are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6); surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2018; body part to which device was applied: hip; surgery description: arthroplasty revision; patient's information: female ; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description provided by sales rep: we used the flat osteotome probe to make initial slots at the head of the stem.Dr (b)(6) explained there was significant bone ingrowth around the head of the stem and wanted to remove this.The handpiece was working perfectly for this section and we encountered zero problems.Following this dr.(b)(6) used manual osteotome's to clear a pathway to use the silver (cemented handpiece).We then attached the flat piercer probe to make slots around the cemented stem.Once the stem was removed, dr (b)(6) attached the 8mm scraper probe to remove the remaining layers of the cement in the canal.Dr.(b)(6) then spent a significant amount of time trying to remove the uncemented acetabular cup.Stryker has a new system to remove this uncemented cup, so he wanted to trial this new system.This then failed and i suggested to use our gold handpiece with the 6mm curved serrated osteotome probe.I first encountered an issue when generator displayed the message "poor feedback release all switches".At this stage dr (b)(6) was using minimal to no pressure and was operating the system correctly.We followed protocol and released all switches and left the machine to rest and reset for 5 seconds.The machine reset by itself.The generator then reset and the led channel then turned yellow meaning activation of the handpiece.We the re-engaged to encounter the handpiece running by itself without pressing the button.Again the generator displayed the message "poor feedback release all switches" without dr (b)(6) actually activating the yellow button.I immediately told to him to cease all operations and suggested to change the cables, as i assumed there was an issue with the cable we were using.The cables were switched and the machine then reactivated.As soon as the new cable was connected the generator displayed the message "handset not detected".I again followed protocol stated in the surgical technique, which suggest an issue with handpiece.I explained to dr (b)(6), we should not continue with the oscar as it has encountered an issue.Dr (b)(6) then opted to finish removing the cup with curved manual osteotome's.The cup popped out after 2 taps and he was happy with this outcome.Following this i conducted my own testing on all handpieces and all cables in both channels.I come to the conclusion that the gold handpiece had failed.I unscrewed the end of the gold handpiece to discover the internal wiring had been compromised and was fried.The complaint report form also indicates: the device failure had no adverse effects on patient.The surgery was not completed with the device.A replacement device was not used to complete surgery: to complete surgery it was used manual osteotomes.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.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.Patient current health condition: n/a.Manufacturer reference number: (b)(4).Distributor's reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 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.(item involved in this event was manufactured by orthosonics ltd).Technical evaluation: the returned device, received on 21 november 2018, was examined by orthofix srl quality engineering department and then sent to the supplier 4easytech for the technical evaluation.The visual check did not evidence any anomalies.The bonecutter for o3 s/n 3bh0158 is not functioning properly.The sealing is lost from the rear body seal and the ceramics inside the device are broken.The generator shows "poor feedback" alert message.Medical evaluation: the information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluations: 15 november 2018 in this event an oscar bonecutter handset stopped working, having been working normally, while attempting acetabular cup removal.The cup was removed easily with manual instruments with a minimal delay.The pictures of the "fried' bonecutter handset make it clear that this instrument has failed.The cause of the failure may become apparent when the device is analysed.20 december 2018 it appears that this bone-cutting handset failed because of a failure of the seal and separately of the internal ceramics.Both of these failures are attributable to wear and tear after multiple uses and cleaning / sterilising cycles.This must be frustrating for the surgeon and for the representative.It would obviously be useful for the hospital to have a second handset.Final comments: the failure found on the handset s/n: (b)(6), is most likely to be attributable to water that entered inside the handset during cleaning and sterilization cycles.This may happen after multiple cleaning and sterilization cycles as a result of wear and tear of silicone o-rings.As regards the issue related to broken ceramics, this is most likely to be attributable to wear and tear of the ceramics inside the device.The two failures are not related, but both can be ascribable to wear and tear of the internal components of the device.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6).Date of initial surgery: on (b)(6) 2018.Body part to which device was applied: hip.Surgery description: arthroplasty revision.Patient's information: female.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description provided by sales rep: we used the flat osteotome probe to make initial slots at the head of the stem.Dr.(b)(6) explained there was significant bone in growth around the head of the stem and wanted to remove this.The handpiece was working perfectly for this section and we encountered zero problems.Following this dr.(b)(6) used manual osteotome's to clear a pathway to use the silver (cemented handpiece).We then attached the flat piercer probe to make slots around the cemented stem.Once the stem was removed, dr.(b)(6) attached the 8mm scraper probe to remove the remaining layers of the cement in the canal.Dr.(b)(6) then spent a significant amount of time trying to remove the uncemented acetabular cup.Stryker has a new system to remove this uncemented cup, so he wanted to trial this new system.This then failed and i suggested to use our gold handpiece with the 6mm curved serrated osteotome probe.I first encountered an issue when generator displayed the message "poor feedback release all switches".At this stage dr.(b)(6) was using minimal to no pressure and was operating the system correctly.We followed protocol and released all switches and left the machine to rest and reset for 5 seconds.The machine reset by itself.The generator then reset and the led channel then turned yellow meaning activation of the handpiece.We the re-engaged to encounter the handpiece running by itself without pressing the button.Again the generator displayed the message "poor feedback release all switches" without dr.(b)(6) actually activating the yellow button.I immediately told to him to cease all operations and suggested to change the cables, as i assumed there was an issue with the cable we were using.The cables were switched and the machine then reactivated.As soon as the new cable was connected the generator displayed the message "handset not detected".I again followed protocol stated in the surgical technique, which suggest an issue with handpiece.I explained to dr.(b)(6), we should not continue with the oscar as it has encountered an issue.Dr.(b)(6) then opted to finish removing the cup with curved manual osteotome's.The cup popped out after 2 taps and he was happy with this outcome.Following this i conducted my own testing on all handpieces and all cables in both channels.I come to the conclusion that the gold handpiece had failed.I unscrewed the end of the gold handpiece to discover the internal wiring had been compromised and was fried.The complaint report form also indicates: the device failure had no adverse effects on patient.The surgery was not completed with the device.A replacement device was not used to complete surgery: to complete surgery it was used manual osteotomes.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.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.Patient current health condition: n/a.Manufacturer reference number: (b)(4).

• Brand Name: BONECUTTER OSTEOTOME HANDSET
• Type of Device: BONECUTTER OSTEOTOME HANDSET
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 8127876
• MDR Text Key: 129781911
• Report Number: 9680825-2018-00100
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• PMA/PMN Number: K093805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OHB300/2
• Device Catalogue Number: OHB300/2
• Device Lot Number: 3BH0158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 12/21/2018
• Patient Sequence Number: 1