MAUDE Adverse Event Report: MAKO SURGICAL CORP. VARIABLE ANGLE CORTICAL SCREW STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	111655
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During femoral rasping, the rasp did not enter as smoothly as anticipated.After rasping, the surgeon noted that the checkpoint screw and variable screw were loose.Upon post-operative examination of the screws, both were found to have worn tips.
Additional Manufacturer Narrative
Reported event.An event regarding wear involving a mako screw was reported.The event was confirmed.Method & results.Product evaluation and results: functional inspection confirmed the reported event.Thread head is worn out, thus causing the device not to function.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device history records cannot be conducted as the lot/serial number was not reported complaint history review: a complaint history review cannot be conducted as the lot/serial number was not reported conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
No new information.

• Brand Name: VARIABLE ANGLE CORTICAL SCREW STERILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23705235
• Report Number: 3005985723-2025-00568
• Device Sequence Number: 18821546
• Product Code: OLO
• UDI-Device Identifier: 00848486017323
• UDI-Public: 00848486017323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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 Catalogue Number: 111655
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/07/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 04/06/2026
• 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: Female