MAUDE Adverse Event Report: ORTHOFIX SRL FLEXIBLE REAMER D 12.5 MM

Catalog Number	171125
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	02/07/2025
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 171125 lot 8265/9 before the market release.No anomalies have been found.The original lot, manufactured in 2002, was comprised of 100 devices.All of them have already been distributed to the market.According to orthofix historical records, since 2002, no other notifications have been received from this specific device code.Technical evaluation the device involved in this event has not yet been received by orthofix srl.The technical evaluation will be performed as soon as 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.
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) date of surgery: on (b)(6) 2025 surgery description: fracture treatment problem observed during: clinical use on patient/intraoperative type of problem: device functional problem event description: "customer statement: we inform you of a serious incident which occurred on february 7, 2025, during a long gamma nail operation.During the operation, the size 12.5 reamer reference (b)(4) from the box of monobloc reamers n°1 completely unwound inside the patient.The removal of this material lasted 2 hours with loss of luck for the patient".The complaint report form also indicates: the device failure had adverse effects on patient the initial surgery was not completed with the device the event led to a delay in the duration of the surgical procedure: 2 hours product is available for return.On february 12, 2025, orthofix received the following additional details: "it took 2 hours to extract the reamer from the centromedullary canal.This prolonged the initial operation.So far, no further complications for the patient".Manufacturer ref: 2025025 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 171125 lot 8265/9 before the market release.No anomalies have been found.The original lot, manufactured in 2002, was comprised of 100 devices.All of them have already been distributed to the market.According to orthofix historical records, since 2002, no other notifications have been received from this specific device code.Technical evaluation the device involved in this event has been lost in transit and therefore not available for the technical evaluation.Conclusion a technical evaluation of the device involved was not possible as it was lost in transit.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), date of surgery: (b)(6) 2025, surgery description: fracture treatment, problem observed during: clinical use on patient/intraoperative, type of problem: device functional problem.Event description: "customer statement: we inform you of a serious incident which occurred on (b)(6) 2025 during a long gamma nail operation.During the operation, the size 12.5 reamer reference 8265/9 from the box of monobloc reamers n°1 completely unwound inside the patient.The removal of this material lasted 2 hours with loss of luck for the patient".The complaint report form also indicates: the device failure had adverse effects on patient, the initial surgery was not completed with the device, the event led to a delay in the duration of the surgical procedure: 2 hours product is available for return.On february 12, 2025, orthofix received the following additional details: "it took 2 hours to extract the reamer from the centromedullary canal.This prolonged the initial operation.So far, no further complications for the patient".On (b)(6) 2025, it was confirmed that the device was lost in transit.Manufacturer ref: (b)(4), distributor ref: (b)(4).

• Brand Name: FLEXIBLE REAMER D 12.5 MM
• Common Device Name: FLEXIBLE REAMER D 12.5 MM
• 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: 21410020
• Report Number: 9680825-2025-00004
• Device Sequence Number: 18521289
• Product Code: HSB
• UDI-Device Identifier: 18032568033724
• UDI-Public: 18032568033724
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K973944
• 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): 04/29/2025

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 Catalogue Number: 171125
• Device Lot Number: 8265/9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2002
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown