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

Model Number 99-91600UE

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 11/11/2022

Event Type  Injury  

Event Description

The information initially provided by local agent indicates: date of initial surgery: (b)(6) 2022.Body part to which device was applied: tibia.Surgery description: fracture treatment.Patient information: 56 years, male,70 kg, 170 cm.Problem observed into treatment/post-operative.Event description: "breakage of the xcaliber body (central part far from the hinges)".The complaint report form also indicates: the device failure had adverse effects on patient (loss of fracture reduction and re-operation).The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical procedure.An additional surgery was required (performed on (b)(6) 2022).A medical intervention (outpatient clinic) was not required.Copies of the operative reports and copies of the x-ray images are available (documentation not received by orthofix).Patient current health condition:patient re-operated with new xcaliber and discharged.Manufacturer ref: (b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code (b)(4), lot b1832339 before the market release.No anomalies have been found.The original lot, manufactured in 2022, was comprised of (b)(4).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 technical evaluation on the returned fixator, received on december 2, 2022, is currently on going.Orthofix srl has requested further information on the event such as: date of the device breakage, circumstances of the device breakage, patient current state of health and copies of the x-ray images pre and post surgeries.Up to date, no other details were made available.As soon as the results of the results of the technical investigation and/or further details are available, orthofix srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 99-91600ue lot b1832339 before the market release.No anomalies have been found.The original lot, manufactured in 2022, was comprised of 40 units.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 december 2, 2022, was examined by orthofix srl quality operations department.The returned fixator was subjected to visual, dimensional and functional check as per orthofix specification.The visual check evidenced that the male part of the fixator is broken near to the ball joint connection to the clamp.The visual examination of the fracture surfaces suggests a failure due to static overload, with a combination of plastic deformations at the edges and final collapse in the middle.The dimensional and functional check, performed where possible as the device is broken, did not evidence any anomalies.Conclusion: the results of the technical investigation confirmed that the returned fixator was originally conforming to orthofix specification.The visual check evidenced that the male part of the fixator is broken near to the ball joint connection to the clamp.The visual examination of the fracture surfaces suggests a failure due to static overload.A medical evaluation of the event was not possible as no medical information was provided.Orthofix srl has requested further information on the event such as: date of the device breakage, circumstances of the device breakage, patient current state of health and copies of the x-ray images pre and post surgeries.Unfortunately, no other details were made available.Based on the information made available on the event, it was not possible to determine the root cause of the problem occurred.It is possible to conclude that the problem occurred is not device related.Should further information become available, orthofix will re-open the investigation of the event.Orthofix historical records indicate that no other notifications have been received in regards to this specific device lot.Orthofix srl continues monitoring the devices on the market.

Event Description

The information initially provided by local agent indicates: date of initial surgery: (b)(6) 2022.Body part to which device was applied: tibia.Surgery description: fracture treatment.Patient information: 56 years, male,70 kg, 170 cm.Problem observed into treatment/post-operative.Event description: "breakage of the xcaliber body (central part far from the hinges)".The complaint report form also indicates: the device failure had adverse effects on patient (loss of fracture reduction and re-operation).The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical procedure.An additional surgery was required (performed on (b)(6) 2022).A medical intervention (outpatient clinic) was not required.Copies of the operative reports and copies of the x-ray images are available (documentation not received by orthofix).Patient current health condition:patient re-operated with new xcaliber and discharged.Manufacturer ref: (b)(4).

• Brand Name: UE XCALIBER METADIAPHYSEAL COMPLETE KIT
• Type of Device: UE XCALIBER METADIAPHYSEAL COMPLETE KIT
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 15930161
• MDR Text Key: 304957617
• Report Number: 9680825-2022-00023
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 99-91600UE
• Device Lot Number: B1832339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG