MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW REAMER D8 L120

Model Number	261048
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
When inserting the 8 mm diameter manual reamer into the left humerus, the reamer broke at its thickest point, two-thirds of the way in, despite normal surgical use.An attempt to extract the piece of reamer resulted in a fracture of the humerus in the patient, leading to a change in the surgical indication, which was discussed with the head of the department.Consequences for patients: increased length of hospital stay / worsening health condition / rehospitalisation-reoperation-transfer / predictable complaints change in surgical indication, switching from total shoulder replacement to humeral nailing in a young patient.
Event or Problem Description
When inserting the 8 mm diameter manual reamer into the left humerus, the reamer broke at its thickest point, two-thirds of the way in, despite normal surgical use.An attempt to extract the piece of reamer resulted in a fracture of the humerus in the patient, leading to a change in the surgical indication, which was discussed with the head of the department.Consequences for patients: increased length of hospital stay / worsening health condition / rehospitalisation-reoperation-transfer / predictable complaints change in surgical indication, switching from total shoulder replacement to humeral nailing in a young patient.

• Brand Name: ARROW
• Common Device Name: ARROW REAMER D8 L120
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: hind chouibani ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 23877864
• Report Number: 3003898228-2025-00005
• Device Sequence Number: 18543013
• Product Code: KWS
• UDI-Device Identifier: 03661489610486
• UDI-Public: 03661489610486
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 261048
• Device Lot Number: B03898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown