MAUDE Adverse Event Report: PHASOR HEALTH, LLC PHASOR DRILL

Model Number	4.50K
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Phasor health's drills have been 100% inspected for various attributes through manufacturing, and the polarity of the drill is dependent upon battery insertion in the correct orientation.Therefore, a problem with one drill does not suggest a problem with the lot as a whole.2.Phasor health reviewed the frequency of units found with reversed polarity as part of in-process inspection, final inspection, and product complaints after distribution.The overall frequency is less than 1:2,000.3.Phasor health initiated a complaint investigation.One additional unit was identified during in-process inspection prior to final inspection, packaging, and sterilization, with one other unit found on post-use analysis thus far.No units were found at the final inspection otherwise.4.Multiple customers received "4.50k lot: 241030450," but only the site with the original complaint reported the issue.5.Direct correspondence would of course aid patient care best (aiding safety while limiting unnecessary measures).6.Phasor health initiated a corrective and preventive action (capa) to address the original complaint, and one additional such specific complaint has been received -- a reversal of battery placement appears the root cause, with corrections including replacement of the few affected drills, and corrective action of secondary inspection of correct polarity instituted as part of the manufacturing process.7.A drill with reversed polarity "may cause [the drill] to operate in the opposite direction than intended.If this occurs, options include reversing the switch so that the drill operates clockwise (and drills correctly in reverse vs.Forward), or utilizing another drill, possibly delaying the surgical procedure." 8.No harm has occurred or is expected to occur for this issue if it were to recur; however, as no other recent lots appear affected, and with the limited complaints as noted, this issue appears contained.
Event or Problem Description
1.Switch activation of lot: 241030450 of phasor health 4.50k fixed disposable cranial access drills may cause them to operate in the opposite direction than intended.2.If this occurs, another drill will be necessary, possibly delaying the surgical procedure.

• Brand Name: PHASOR DRILL
• Common Device Name: PHASOR DRILL
• Manufacturer (Section D): PHASOR HEALTH, LLC; 8944 kirby drive; houston TX 77054
• Manufacturer (Section G): PHASOR HEALTH, LLC; 8944 kirby drive; houston TX 77054
• Manufacturer Contact: ray king ; 8944 kirby drive; houston, TX 77054 ; 2127296161
• MDR Report Key: 21866668
• Report Number: 3016577622-2025-00001
• Device Sequence Number: 18055823
• Product Code: HBE
• UDI-Device Identifier: B775450K0
• UDI-Public: B775450K0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

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
• Device Model Number: 4.50K
• Device Lot Number: 241030450
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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