MAUDE Adverse Event Report: ORTHOFIX SRL XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE

Model Number 99-91215

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code: (b)(4); batch#: b1419340, before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 20 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 technical evaluation on the returned kit, received on october 15, 2020, is currently on going.Medical evaluation: the information available on the case was sent to our medical evaluator.A preliminary medical evaluation is ongoing and will be finalized once the results of the technical evaluation will be 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

On october 15, 2020, orthofix srl received an xcaliber kit together with a complaint form, which included the following information: hospital name: (b)(6).Surgeon name: (b)(6).Data of surgery: (b)(6) 2020.Body part to which device was applied: left tibia.Patient information: (b)(6) years, male, (b)(6).Date of surgery: fracture treatment.Type of problem: device functional problem event description: "in the first 7 days there was a failure of the device (proximal part) with fracture displacement and need for a second surgery ((b)(6))." the complaint report form included also copies of the operative reports and copies of the x-ray images.Manufacturer reference number: (b)(4).

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 99-91215 batch b1419340 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 20 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 kit, received on october 15, 2020, was examined by orthofix srl quality engineering department.The kit was subjected to visula, dimensional and functional check as per orthofix specification.No anomalies have been found.The returned kit was also subjectd to static test as per orthofix validation protocol.The kit met the design criteria; no anomalies have been detected.The results of the technical analysis confirmed the conformity of the returned kit to orthofix specification.Medical evaluation: the information 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."the tibia in this leg is very abnormal.In the mid-diaphysis the bone is enlarged to at least x2 diameter and the cortex is very thin.This is a fracture through abnormal bone.Very nice bone screw application.This metadiaphyseal xcaliber fixator appeared to be normal when examined after it was returned".Conclusion : the results of the technical analysis confirmed the conformity of the returned kit to orthofix specification.Orthofix srl required further information on the event, such as current health condition of the patient and information about the code of the fixator used to replace the complained kit.Unfortunately this infomation was not made available.Based on the information made available on the event, it was not possible to determine the root cause of the problem occurred into treatment, which remain unknown.Should further information become available, orthofix will re-open the investigation of the event.Orthofix 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.

Event Description

On october 15, 2020, orthofix srl received an xcaliber kit together with a complaint form which included the following information: hospital name: (b)(6).Surgeon name: dr.(b)(6).Data of surgery: (b)(6) 2020.Body part to which device was applied: left tibia.Patient information: 25 years, male, 90 kg, 180 cm.Date of surgery: fracture treatment.Type of problem: device functional problem.Event description: "in the first 7 days there was a failure of the device (proximal part) with fracture displacement and need for a second surgery ((b)(6) 2020.)".The complaint report form included also copies of the operative reports and copies of the x-ray images.No other information was given.Manufacturer reference number: (b)(4).

• Brand Name: XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE
• Type of Device: XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 10828669
• MDR Text Key: 218643406
• Report Number: 9680825-2020-00058
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 18032568867206
• UDI-Public: (01)18032568867206(11)191204(17)241104(10)B1419340
• Combination Product (y/n): N
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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
• Device Operator: Health Professional
• Device Model Number: 99-91215
• Device Catalogue Number: 99-91215
• Device Lot Number: B1419340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 90