MAUDE Adverse Event Report: ORTHOFIX SRL UE XCALIBER ANKLE COMPLETE KIT

Catalog Number	99-91647UE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of historical records.Orthofix checked the internal records related to the controls made on the device code 99-91647ue lot: b4856633 before the market release.No anomalies have been found.The original lot, manufactured in 2024, was comprised of 9 devices.All of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device lot.Technical evaluation: the device involved in this event has been discarded by the hospital and therefore not available for the technical evaluation.Conclusions: a technical evaluation of the device involved was not possible as it was discarded at the hospital.Considering the information provided, it is not possible to draw any conclusion regarding the complained device failure.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.In case further information or the device concerned are provided, orthofix will finalize the investigation.Orthofix continues monitoring the devices on the market.
Event or Problem Description
The information initially provided by local distributor indicates: event notified by the hospital to ansm; ansm ref: (b)(4).Hospital name: (b)(6).Correspondent de vigilance: madame (b)(6).Device code: 99-91647ue.Device lot: b4856633.Date of surgery: on (b)(6) 2024.Date of event: 08/11/2024.Event description: vis servent au maintien du mécanisme (au biveau de la structure pour verrouiller la position) non fonctionnel, la position ne se bloque pas patient current condition: rallongement du temps opératoire de 2h pour récupérer un fixateur externe auprès d'un autre établissement.Surveillance simple à ce jour, prélèvement bactério négatifs le 19/11 action taken: dépannage d'un dispositif de remplacement auprès d'un autre établissement.On november 22, 2024, orthofix srl received information that the hospital discarded the complained device.On november 25, 2024, orthofix received the following additional details: surgeon's name: dr.(b)(6).Body part to which device was applied: fracture bimaleolaire droite.Surgery description: fracture treatment.Patient information: 80 years, female, 168 cm, 90 kg.Event description: there was a problem with the central screw, it was seized up, the head was stuck and couldn't close.As they didn't have a 2nd kit on site, they had to ask another hospital.This prolonged the surgery.The device failure had adverse effects on patient: the surgery was extended to allow time for delivery of a new kit (plus 1h30).The initial surgery was not completed with the device.A replacement device of same model was not immediately available to complete surgery the event led to a delay in the duration of the surgical procedure: 1h30.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative report are available (not received by orthofix).Copies of the x-ray images are not available.Product is not available for return.Manufacturer ref: (b)(4).Distributor ref: (b)(4).Ansm hospital report ref: (b)(4).
Event or Problem Description
The information initially provided by local distributor indicates: event notified by the hospital to ansm; ansm ref: (b)(4), hospital name: (b)(6) hopital, correspondant de vigilance: (b)(6), device code: 99-91647ue, device lot: b4856633, date of surgery: on (b)(6),2024, date of event: 08/11/2024.Event description: vis servent au maintien du mécanisme (au biveau de la structure pour verrouiller la position) non fonctionnel, la position ne se bloque pas patient current condition: rallongement du temps opératoire de 2h pour récupérer un fixateur externe auprès d'un autre établissement.Surveillance simple à ce jour, prélèvement bactério négatifs le 19/11 action taken: dépannage d'un dispositif de remplacement auprès d'un autre établissement.On november 22, 2024, orthofix srl received information that the hospital discarded the complained device.On november 25, 2024, orthofix received the following additional details:- surgeon's name: dr (b)(6).Body part to which device was applied: fracture bimaleolaire droite surgery description: fracture treatment.Patient information: 80 years, female, 168 cm, 90 kg.Event description: there was a problem with the central screw, it was seized up, the head was stuck and couldn't close.As they didn't have a 2nd kit on site, they had to ask another hospital.This prolonged the surgery.The device failure had adverse effects on patient: the surgery was extended to allow time for delivery of a new kit (plus 1h30) the initial surgery was not completed with the device a replacement device of same model was not immediately available to complete surgery the event led to a delay in the duration of the surgical procedure: 1h30 an additional surgery was not required.A medical intervention (outpatient clinic) was not required copies of the operative report are available (not received by orthofix).Copies of the x-ray images are not available.Product is not available for return.Manufacturer ref: (b)(4), distributor ref: (b)(4), ansm hospital report ref: (b)(4).
Additional Manufacturer Narrative
Analysis of historical records orthofix checked the internal records related to the controls made on the device code 99-91647ue lot b4856633 before the market release.No anomalies have been found.The original lot, manufactured in 2024, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device lot.Technical evaluation the device involved in this event has been discarded by the hospital and therefore not available for the technical evaluation.The technical evaluation will be performed should the device becomes available.As soon as the results of the investigation are available, orthofix will provide a follow up report.Orthofix continues monitoring the devices on the market.

• Brand Name: UE XCALIBER ANKLE COMPLETE KIT
• Common Device Name: UE XCALIBER ANKLE COMPLETE KIT
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo; verona, 37012 ; IT 37012
• MDR Report Key: 20794900
• Report Number: 9680825-2024-00064
• Device Sequence Number: 6832924
• Product Code: JDW
• UDI-Device Identifier: 18032937169719
• UDI-Public: (01)18032937169719(11)240703(12)290508(10)B4856633
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 99-91647UE
• Device Lot Number: B4856633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 90 KG