MAUDE Adverse Event Report: ORTHOFIX SRL OSCAR - LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES

Model Number 1

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4).Orthofix (b)(4) 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 technical investigation are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide 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: product code: ohre2001su (long extension reducer bar for single use probes).Batch number: g160307.Quantity: 1.Hospital name: (b)(6).Surgeon's name: (b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: no response received.Surgery description: arthroplasty revision.Patient information: (b)(6) years, male.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "problem occurred week commencing (b)(6) 2020, mr (b)(6) operating.Reported to be "not working" could not be more specific, also extension bar broke during procedure.I understand these have been retrieved.Poor feedback release all switches.Hand pieces cannot melt cement".The complaint report form also indicated: the device failure caused adverse effects on patient (loss of fracture reduction, loss of achieved correction).The initial surgery was completed with the device.The event led to a delay in the duration of the surgical procedure (approximately 30 minutes).Information about need of additional surgery or medical intervention is not available.Copies of the operative reports and x-ray images are not available.Product is available for return.Information about patient current health condition is not available.Manufacturer ref: (b)(4).Distributor ref: (b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code: ohre2001su, batch g160307 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received from this specific device lot.Technical evaluation: a technical evaluation of the device concerned was not possible as it was not returned.The technical evaluation will be performed should the device becomes available.Medical evaluation: the information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."we know very little about this event.A male patient of 80 years was having an arthroplasty revision with an oscar kit, and the oscar kit was being used to melt the cement for removal.Apparently this did not work, and this seems to have been the case from the beginning, although this is not definite.Also at some stage an unidentified extension bar broke and was retrieved.We are not told what happened after this, except that the operation took an extra 30 minutes.Presumably the operation was completed with the standard hand instruments.We are not told anything about the health of the patient.Also at some stage an extension bar broke, presumably during manipulation.I do not think that the breakage of the extension bar had any relevance for the health of the patient.The broken section was removed from the wound, as are all instruments that are used in the operation.It seems that the hospital might have started a hip revision with an oscar system that was not working properly.The operation was completed as planned, as far as we know, with hand instruments.I do not think that the extension bar breakage had any significance for the patient".Conclusion: a technical evaluation of the device concerned was not possible as it was not returned.The technical evaluation will be performed should the device becomes available.A complete medical evaluation of the event was not performed as no information about the medical procedure, diagnosis and x-rays and information about patient health conditions have been made available.Based on the information available on the event, it was not possible to finalize the investigation and determine the root cause of the event notified.Orthofix srl historical records shows that no other similar notifications have been received in regards to this specific device lot.Should further information and/or the device used be provided, orthofix srl will promptly re-open the investigation on the case.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: product code: ohre2001su (long extension reducer bar for single use probes), batch number: g160307, quantity: 1, hospital name: (b)(6), date of initial surgery: w/c on (b)(6) 2020, body part to which device was applied: no response received, surgery description: arthroplasty revision, patient information: 80 years, male, problem observed during: clinical use on patient/intraoperative, type of problem: device functional problem.Event description: "problem occurred week commencing on (b)(6) 2020, mr.(b)(6) operating.Reported to be "not working" could not be more specific, also extension bar broke during procedure.I understand these have been retrieved.Poor feedback release all switches.Hand pieces cannot melt cement".The complaint report form also indicated: the device failure had adverse effects on patient (loss of fracture reduction, loss of achieved correction).The initial surgery was completed with the device.The event led to a delay in the duration of the surgical procedure (approximately 30 minutes).Information about need of additional surgery or medical intervention is not available.Copies of the operative reports and x-ray images are not available.Product is available for return.Information about patient current health condition is not available.Manufacturer ref: (b)(4).

• Brand Name: OSCAR - LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES
• Type of Device: OSCAR - LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 9761945
• MDR Text Key: 190332723
• Report Number: 9680825-2020-00022
• Device Sequence Number: 1
• Product Code: JDX
• UDI-Device Identifier: 18056099649964
• UDI-Public: (01)18056099649964(11)190212(10)G160307
• 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: 04/08/2020

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: 1
• Device Catalogue Number: OHRE2001SU
• Device Lot Number: G160307
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR