MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE REAMER D8.0 L200 L480 ROUNDED

Catalog Number	60000411.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As per the reporter, during the surgical procedure for a fitbone nail implantation, they experienced a breakage of the tip of the reamer.Fragments of the reamer were left in the intramedullary canal.
Additional Manufacturer Narrative
The returned device, received on november 19, 2025 is currently under technical investigation.A follow up report will be provided as soon as the results of the technical investigation are available.
Additional Manufacturer Narrative
A review of the quality database for the past 24 months revealed no similar complaints.Additionally, no nonconformities were identified for the reported lot, which was manufactured in 2023.Therefore, the case is considered isolated.Based on the information provided and according to the operative technique fb-2205-opt associated with the fitbone device, the reamer is introduced into the intramedullary canal through the tube, which protects the soft tissues and guides the reamer.During distal reaming, the procedure may be performed manually (using a t handle) or with the appropriate step reamer, and the use of a power drill should be avoided.Subsequently, after insertion of the dummy nail, blocking screws are placed if necessary.
Event or Problem Description
As per the reporter, during the surgical procedure for a fitbone nail implantation, they experienced a breakage of the tip of the reamer.Fragments of the reamer were left in the intramedullary canal.

• Brand Name: FITBONE REAMER D8.0 L200 L480 ROUNDED
• Common Device Name: FITBONE REAMER D8.0 L200 L480 ROUNDED
• 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: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 23602639
• Report Number: 9680825-2025-00046
• Device Sequence Number: 13256521
• Product Code: HSB
• UDI-Device Identifier: 18053340342384
• UDI-Public: 18053340342384
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163368
• 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): 03/26/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60000411.
• Device Lot Number: 922060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female