MAUDE Adverse Event Report: ORTHOFIX SRL RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM - STERILE

Model Number	99-36501
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 99-36501 batch b1845741 before the market release.No anomalies have been found.The original lot, manufactured in 2022, was comprised of 70 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: the device involved in this event has not yet been received by orthofix srl.Orthofix srl 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.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 or Problem Description
The information initially provided by local distributor indicates: product code: 99-36501.Batch number: b1845741.Hospital name: hospital (b)(6).Date of initial surgery: (b)(6) 2023.Body part to which device was applied: wrist.Surgery description: fracture treatment.Patient information: 60 years, female.Problem observed during: into treatment/post-operative.Event description: device breakage into treatment.The complaint report form also indicates: 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) 2023).A medical intervention (outpatient clinic) was not required.Product is available for return.Product has been properly cleaned and disinfected.On may 24, 2023, orthofix srl received the following additional information from the local distributor: name of the surgeon: dr.(b)(6).Date of the breakage of the device: (b)(6) 2023.Circumstances of the failure (what was doing the patient at the moment of the device failure?): nothing, the kneecap came loose.No adverse effects on patient.During the revision surgery the fixator was removed, no other devices were used.Fixator removal was scheduled shortly but on arrival with the broken fixator they removed it and it appears that the fracture was already healed.The patient is in good health condition.Copies of the x-ray images are not available.The fixator was removed in the operating theatre.Manufacturer ref: 2023092.Distributor ref: (b)(4).
Event or Problem Description
The information initially provided by local distributor indicates: product code: 99-36501.Batch number: b1845741.Hospital name: (b)(6).Date of initial surgery: (b)(6), 2023.Body part to which device was applied: wrist.Surgery description: fracture treatment.Patient information: 60 years, female.Problem observed during: into treatment/post-operative.Event description: device breakage into treatment.The complaint report form also indicates: 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), 2023).A medical intervention (outpatient clinic) was not required.Product is available for return.Product has been properly cleaned and disinfected.On may 24, 2023, orthofix srl received the following additional information from the local distributor: name of the surgeon: dr.(b)(6).Date of the breakage of the device: (b)(6) 2023.Circumstances of the failure (what was doing the patient at the moment of the device failure?): nothing, the kneecap came loose.No adverse effects on patient.During the revision surgery the fixator was removed, no other devices were used.Fixator removal was scheduled shortly but on arrival with the broken fixator they removed it and it appears that the fracture was already healed.The patient is in good health condition.Copies of the x-ray images are not available.The fixator was removed in the operating theatre.Manufacturer ref: (b)(4) distributor ref: (b)(4).
Additional Manufacturer Narrative
Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 99-36501, batch b1845741 before the market release.No anomalies have been found.The original lot, manufactured in 2022, was comprised of 70 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 the returned fixator, received on may 31, 2023, was examined by orthofix srl quality operations department.The device was subjected to visual and dimensional check as per orthofix specifications.The visual check confirmed the problem notified.The device is broken in correspondence to the sphere of the female clamp.The dimensional check did not evidence any anomalies.The returned fixator was then sent to an external laboratory for the raw material check and the failure investigation.The results of the technical investigation evidenced the raw material conformity to orthofix specification.The device broke due to fatigue failure mainly related to the flexural loads to which the device was subjected during application.Medical evaluation a medical evaluation of the case was not performed as no information about the medical procedure and x-rays have been made available.Conclusion the results of the technical investigation evidenced the raw material conformity to orthofix specification.The device broke due to fatigue failure mainly related to the flexural loads to which the device was subjected during application.A medical evaluation of the case was not performed as no information about the medical procedure and x-rays have been made available.Based on the results of the technical evaluation, which confirmed the device conformity to orthofix specifications, orthofix can conclude that the problem that occurred is not device related.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.Orthofix continues monitoring the products on the market.

• Brand Name: RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM - STERILE
• Common Device Name: RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM - STERILE
• 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, 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 17008757
• Report Number: 9680825-2023-00019
• Device Sequence Number: 6975842
• Product Code: JDW
• UDI-Device Identifier: 18032568861648
• UDI-Public: (01)18032568861648(11)220707(17)270512(10)B1845741
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K955848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 99-36501
• Device Catalogue Number: 99-36501
• Device Lot Number: B1845741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female