MAUDE Adverse Event Report: ORTHOFIX SRL XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE

Model Number	99-91245
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 99-91245, batch b1237875 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4).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 evaluation become available.Orthofix (b)(4) has requested further information on the event such as: patient age, sex and weight.Better explanation of the problem had with the device.Patient adverse effects, if any, date of the additional surgery, copies of the operative reports, copies of the x-ray images, information about patient current health condition.As soon as further information is available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.
Event or Problem Description
The information provided by the local distributor indicates: device code: 99-91245.Batch number: b1237875.Quantity: 1.Hospital name: (b)(6).Surgeon's name: dr (b)(6).Date of surgery: (b)(6) 2018.Body part to which device was applied: ankle.Surgery description: fracture treatment.Patient information: no response.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: "by the (b)(6) 2018, patient has been treated for an external fixator on right ankle.By the (b)(6) 2018, he came back because fixator got disadapted".The complaint report form also indicates: the surgery was completed with the device.The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required.No other information was provided.(b)(4).
Event or Problem Description
The information provided by the local distributor indicates: device code: 9991245.Batch number: b1237875.Quantity: 1.Hospital name: (b)(6) hospitalier.Surgeon's name: dr (b)(6).Date of surgery: (b)(6) 2018.Body part to which device was applied: ankle.Surgery description: fracture treatment.Patient information: no response.Problem observed during: into treatment/postoperative.Type of problem: device functional problem.Event description: "le (b)(6) 2018, un patient a été pres en charge par un fe cheville droite.Le (b)(6) 2018, le patient revient con le fe s'est disasapté"."by (b)(6) 2018, patient has been treated for an external fixator on right ankle.By the (b)(6) 2018, he came back because fixator got disadapted." the complaint report form also indicates: the surgery was completed with the device.The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required.On september 7, 2018 orthofix received the following additional information: patient is 57 year old, 97 kg, 1m70.Patient was brought to hospital following fall from a chair.Problem had with the device: "dismantling of fixator at right leg, new reduction and new fixator put in place in case the first one was not efficient." the device failure did not have any adverse effects on patient.The additional surgery was performed on (b)(6) 2018.Copies of the operative report and copies of the pre and postoperative xrays are not available information about patient current health condition: x rays are ok on (b)(6) 2018.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).
Additional Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 99-91245, batch b1237875 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the returned fixator, received on september 12th, 2018 were examined by orthofix srl quality engineering department.The returned device was subjected to visual, dimensional and functional check as per orthofix specification.The visual check evidenced that the surface of the fixator is opaque and some components are slightly discoloured.No other anomalies have been found.The dimensional and functional check did not evidence any anomalies.The results of the technical evaluation concluded that the returned fixator is still conforming to orthofix specification and it could function as intended.Medical evaluation: the information made available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed.On (b)(6) 2018: "it seems that this patient was a male, 97 kg and 1m 70 tall.The initial injury on (b)(6) required the application of an xcaliber ankle fixator.All was well at home until the patient fell from a chair on (b)(6).This damaged the fixator and caused a loss of position.A new fixator was applied on (b)(6) and follow up x-rays on (b)(6) confirm that all is well.I think that it is not correct to describe the incident as a 'fixator malfunction'.The fixator did the job for which is was designed until the patient fell." on september 19, 2018 with the results of the technical evaluation: "it seems that the patient fell from a chair on (b)(6), and in spite of information that the fixator had broken, the sudden extra load on the fixator must have caused one or both ball joints to give way, with the result that the position was lost.This technical report makes it clear that the fixator was not damaged by this fall, and indeed continues to perform completely to specification.The conclusion can only be that the fixator ball joint or joints were strained beyond their design criteria as a result of this fall, and were forced into another position so that the position of the bone was altered." final comments: the results of the technical evaluation concluded that the returned fixator is still conforming to orthofix specification and it could function as intended.The last medical evaluation evidenced as follows: "it seems that the patient fell from a chair on (b)(6), and in spite of information that the fixator had broken, the sudden extra load on the fixator must have caused one or both ball joints to give way, with the result that the position was lost.This technical report makes it clear that the fixator was not damaged by this fall, and indeed continues to perform completely to specification.The conclusion can only be that the fixator ball joint or joints were strained beyond their design criteria as a result of this fall, and were forced into another position so that the position of the bone was altered." orthofix can therefore conclude that the problem that occurred is not device related.Orthofix srl historical records show that no other notifications have been received in regards to this specific device lot.Orthofix srl continues monitoring the devices on the market.

• Brand Name: XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE
• Common Device Name: XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 7849899
• Report Number: 9680825-2018-00079
• Device Sequence Number: 1719974
• Product Code: JDW
• UDI-Device Identifier: 18032568867213
• UDI-Public: (01)18032568867213(11)180419(17)230319(10)B1237875
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 99-91245
• Device Catalogue Number: 99-91245
• Device Lot Number: B1237875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 97