MAUDE Adverse Event Report: ORTHOFIX SRL SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE

Model Number OHP2062SU

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/24/2019

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code ohp2062su batch b1234097 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 26 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical analysis: the involved device has not been returned to orthofix srl yet.The technical evaluation will be performed as soon as the device is received.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 further information on the case is available.Orthofix srl has requested further information on the event such as patient's details and patient's current health condition, estimation of increased surgery time, copy of x-ray images and product return.Unfortunately this information has not been made available so far.As soon as the results of the investigation are available, orthofix srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information initially provided by local distributor indicates: hospital name: (b)(6).Case date: (b)(6) 2019.Surgeon: (b)(6).Body part to which device was applied: hip.Surgery description: arthroplasty revision problem observed during: clinical use on patient/intraoperative.Event description: i wanted to give you notice that the recent hire to (b)(6) of the oscar 2 equipment resulted in the failure of a probe.The hospital has recorded internally the failure as an incident.The probe fractured and with the fractured part-probe not retrievable from the patient due to heavy blood loss incurred during the early part of the procedure (not due to the probe issue).No more time could be afforded to search out the part-probe and as a result it was left in situ.A check was performed by x-ray to locate the part-probe.The complaint report form also indicated: the device failure had no 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: details not available, 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: unavailable.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code ohp2062su; batch b1234097 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 26 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical analysis: a technical evaluation of the device involved was not possible, as the device was discarded by the hospital and therefore it is not available for the technical investigation.Medical evaluation: the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed.In this case a patient (details unknown) was having a hip prosthesis revision.Heavy blood loss occurred during the first part of the operation (not related to use of an orthofix product).During cement removal a probe was broken and the detached part left inside the patient.It was not possible to attempt to retrieve this part because of the blood loss.An x-ray was taken of the bone after the probe breakage.This confirms a retained component.We do not know why the probe broke.We need to have the probe returned and to see the x-ray.Final comments: a technical evaluation of the device involved was not possible, as the device was discarded by the hospital and therefore it is not available for the technical investigation.A complete medical evaluation of the case was not performed as some information about the medical procedure was not made available, i.E.Copies of the x-ray images and copies of the operative report.Considering the information provided, it was not possible to determine the root cause of the breakage occurred.Should further information become available, orthofix srl will finalize the investigation.Orthofix srl has requested further information on the event such as patient's details, estimation of delay in surgery time and copy of x-ray images.Unfortunately, this information was not made available.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix srl continues monitoring the devices on the market.(b)(4).

Event Description

The information initially provided by local distributor indicates: hospital name: (b)(6) clinic, (b)(6), ireland.Case date: (b)(6) 2019.Surgeon: mr.(b)(6).Body part to which device was applied: hip.Surgery description: arthroplasty revision.Problem observed during: clinical use on patient/intraoperative event description: i wanted to give you notice that the recent hire to (b)(6) clinic of the oscar 2 equipment resulted in the failure of a probe.The hospital has recorded internally the failure as an incident.The probe fractured and with the fractured part-probe not retrievable from the patient due to heavy blood loss incurred during the early part of the procedure (not due to the probe issue).No more time could be afforded to search out the part-probe and as a result it was left in situ.A check was performed by x-ray to locate the part-probe.The complaint report form also indicated: the device failure had no 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: details not available.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: unavailable.Further information received on 12th november 2019.The probe is still at the hospital and the agent is still trying to get this returned to us for inspection.The hospital have no plans at the moment to extract the broken probe (as advised by the agent).Further information received on 5th december 2019.The agent today confirmed that the hospital have discarded the broken probe and is not available for return.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE
• Type of Device: SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 9260928
• MDR Text Key: 183479054
• Report Number: 9680825-2019-00070
• Device Sequence Number: 1
• Product Code: JDX
• UDI-Device Identifier: 18056099649803
• UDI-Public: (01)18056099649803(11)180323(17)230223(10)B1234097
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: OHP2062SU
• Device Catalogue Number: OHP2062SU
• Device Lot Number: B1234097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention