MAUDE Adverse Event Report: SURGIFY MEDICAL OY SURGIFY HALO; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	40.000.SEE.H1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation findings identified multiple conditions during the procedure that fell outside the ifu-specified parameters: intraoperative contacts between the device and the metal suction tube, excessive force used, exceeding the maximum continuous use time, and insufficient irrigation.These deviations from the ifu are considered likely contributing factors to the reported outcome.This report does not constitute an admission that surgify medical or its employees caused or contributed to the event.If any further information becomes known that could change or alter any conclusions or information, a supplemental report will be filed accordingly.
Event or Problem Description
During a clinical study procedure (open spinal surgery), a small metal fragment dislodged from the burr.The device stayed intact otherwise; the fragment was fully retrieved intraoperatively, and no patient harm resulted.

• Brand Name: SURGIFY HALO
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): SURGIFY MEDICAL OY; otakaari 5; espoo, 02150 ; FI 02150
• Manufacturer (Section G): SURGIFY MEDICAL OY; otakaari 5; espoo, 02150 ; FI 02150
• Manufacturer Contact: jukka kreander ; otakaari 5; espoo, 02150 ; FI 02150
• MDR Report Key: 25329224
• Report Number: 3015392173-2026-00003
• Device Sequence Number: 9954471
• Product Code: HBE
• UDI-Device Identifier: 06429811532076
• UDI-Public: (01)06429811532076(17)301231(10)10334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 40.000.SEE.H1
• Device Catalogue Number: 40.000.SEE.H1
• Device Lot Number: 10334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown