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

Model Number OHP2062SU

Device Problem Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records on july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for (b)(4) devices, also for the ones manufactured and released to the market by orthosonics ltd.The item involved in this event is manufactured by orthosonics ltd.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 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 investigation are available.As soon as the results of the investigation will be available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

He information initially provided by local distributor indicates: device code: (b)(4) (single use 6mm piercer probe - slim - 180mm - sterile).Batch number: wo/22725/a; quantity: 1; hospital name: (b)(6) hospital.; surgeon name: dr.(b)(6); date of surgery: (b)(6) 2018; body part to which device was applied: hip; surgery description: arthroplasty revision; patient information: unknown; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: "per the tm ((b)(6) 2018) - during hip revision on a hip arthroplasty 6mm pierce probe item (b)(6) with lot #wo/22725/a used for procedure.This probe is very thin doctor bends on it and the tip broke while in patient, additional time of 20 mins.Added to surgery.Adverse effect on patient is a broken piece of the probe is left inside patient.Doctor then used cement it keep it in place to leave in patient".The complaint report form also indicates: the device failure had adverse effects on patient (un-retrieved device fragments); the initial surgery was not completed with the device; a replacement device was immediately available to complete the surgery; 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 report are not available; copies of the x-ray images are not available; patient current health conditions: unk.Note and comments: larger oscar probe 10mm was used to complete the surgery.On may 29, 2018, orthofix srl received the following additional details: "the field patient (b)(6) male.He left the or in stable condition".On may 30, 2018, orthofix srl received copies of the patient x-rays.(b)(4).

Manufacturer Narrative

Technical evaluation: on july 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.The item involved in this event is manufactured by orthosonics ltd.The returned device, received on june 25th, 2018, was examined by orthofix srl quality engineering department.The device was subjected to visual and functional check as per orthofix specification.The visual check confirmed the problem notified: the piercer probe is broken at about 147.40 mm from thread bottom.The tip part is not available for the analysis as it was left in patient bone.No other visual anomalies have been found.The dimensional check, performed where possible as the probe is broken, did not evidence any anomalies.The device was then sent to an external laboratory for the raw material check and failure analysis.The results of the technical analysis confirmed the raw material conformity to specification.The device broke due to bending fatigue failure.This breakage is attributable to the stresses acting on the probe (ultrasound or manual stresses) during clinical use.Medical evaluation the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed."in this event an 89 year old patient was having a hip prosthesis revision.Cement had to be removed and the surgeon was using a slim shafted piercer probe during the surgery.The tip of the probe broke off and remain in the distal femur.It seems that the prosthesis revision was completed as planned with a second probe.I note that this probe has been designed primarily for use in the upper limb, and warnings are given that it is more fragile because of its thin diameter.It seems that in this case the surgeon put too much bending load on the instrument and it broke.I note that the probe in question is made from titanium alloy and is therefore biocompatible and should be completely inert inside the bone.From the description, it seems clear that the surgeon produced a bending load on the instrument that caused it to break.I am sure that the decision to leave it in situ was the best one for the patient.The small piece of metal will cause no problems for the patient and the efficacy and life expectancy of the prosthesis above it will not be affected at all".Final comments the results of the technical analysis confirmed the raw material conformity to specification.The device broke due to bending fatigue failure.This breakage is attributable to the stresses acting on the probe (ultrasound or manual stresses) during clinical use.The medical evaluation evidenced as follows: "in this event an 89 year old patient was having a hip prosthesis revision.Cement had to be removed and the surgeon was using a slim shafted piercer probe during the surgery.The tip of the probe broke off and remain in the distal femur.It seems that the prosthesis revision was completed as planned with a second probe.I note that this probe has been designed primarily for use in the upper limb, and warnings are given that it is more fragile because of its thin diameter.It seems that in this case the surgeon put too much bending load on the instrument and it broke.I note that the probe in question is made from titanium alloy and is therefore biocompatible and should be completely inert inside the bone.From the description, it seems clear that the surgeon produced a bending load on the instrument that caused it to break.I am sure that the decision to leave it in situ was the best one for the patient.The small piece of metal will cause no problems for the patient and the efficacy and life expectancy of the prosthesis above it will not be affected at all".Based on the results of the technical evaluation, which confirmed the device conformity to specification, and on the evidences deriving from the medical evaluation, orthofix can conclude that the breakage that occurred is attributable to the stresses acting on the probe (ultrasound or manual stresses) during clinical use.Orthofix srl continues monitoring the devices on the market.- attachment: [2018122_fda medwatch cover letter_follow up 1.Pdf].

Event Description

The information initially provided by local distributor indicates: device code: ohp2062su (single use 6mm piercer probe slim 180mm sterile).Batch number: wo/22725/a.Quantity: 1.Hospital name: (b)(6) hospital.Surgeon name: dr.(b)(6).Date of surgery: (b)(6) 2018.Body part to which device was applied: hip.Surgery description: arthroplasty revision.Patient information: unknown.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "per the tm ((b)(6) 2018) during hip revision on a hip arthroplasty 6mm pierce probe item ohp2062su with lot #wo/22725/a used for procedure.This probe is very thin doctor bends on it and the tip broke while in patient, additional time of 20 mins.Added to surgery.Adverse effect on patient is a broken piece of the probe is left inside patient.Doctor then used cement it keep it in place to leave in patient" the complaint report form also indicated: the device failure had adverse effects on patient (unretrieved device fragments).The initial surgery was not completed with the device.A replacement device was immediately available to complete the surgery.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 report are not available.Copies of the xray images are not available.Patient current health conditions: unk.Note and comments: larger oscar probe 10mm was used to complete the surgery on (b)(6) 2018, orthofix srl received the following additional details: "the field patient lr is an 89 year old male.He left the or in stable condition" on (b)(6) 2018, orthofix srl received copies of the patient xrays.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, italy 37012 ; IT 37012
• MDR Report Key: 7599891
• MDR Text Key: 111189238
• Report Number: 9680825-2018-00049
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OHP2062SU
• Device Catalogue Number: OHP2062SU
• Device Lot Number: WO/22725/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR