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

Model Number	30.000.SEE.U2
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	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation findings identified multiple conditions during the procedure that fell outside the ifu-specified parameters: significantly exceeding the maximum drilling time and exceeding the specified rpm limit.These deviations from the ifu are considered to have caused 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.Submission of this report was delayed for one day due to inaccessibility of the fda electronic submissions gateway nextgen (esg nextgen) on the report due date of 22 june 2026.Access was attempted from multiple devices across two independent internet connections.No scheduled maintenance was posted for this date.The report was fully completed and ready for submission on the due date.Submission was made as soon as gateway access was restored.Documentation of access attempts and correspondence with fda has been retained in the mdr event file pursuant to 21 cfr 803.18(b)(1).
Event or Problem Description
During a spine procedure the burr disassembled.The use time of the device exceeded approximately 6 times the use time specified in the ifu.Also 50% higher rpm was used compared to the rpm stated in the ifu.No reported harm was caused to the patient.Post-operative pictures (taken for other reasons) confirmed that no burr fragments remained in the body.

• Brand Name: SURGIFY HALO
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): SURGIFY MEDICAL OY; otakaari 5; espoo, na 02150 ; FI 02150
• Manufacturer (Section G): SURGIFY MEDICAL OY; otakaari 5; espoo, na 02150 ; FI 02150
• Manufacturer Contact: jukka kreander ; otakaari 5; espoo, na 02150 ; FI 02150
• MDR Report Key: 25589715
• Report Number: 3015392173-2026-00004
• Device Sequence Number: 9995198
• Product Code: HBE
• UDI-Device Identifier: 06429811532229
• UDI-Public: (01)06429811532229(17)310131(10)10362
• Combination Product (Y/N): N
• PMA/510(K) Number: K253627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: 30.000.SEE.U2
• Device Catalogue Number: 30.000.SEE.U2
• Device Lot Number: 10362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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