MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR VARIABLE ANGLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	206967
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A visual inspection was performed and dark gray particles were detected inside the hip end effector.The particles are apparently generated by the rotary movement of the instruments.It is recommended to replace these instruments until the end of the investigation process.

• Brand Name: HIP END EFFECTOR VARIABLE ANGLE
• 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: 22373917
• Report Number: 3005985723-2025-00302
• Device Sequence Number: 8025654
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K170593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 206967
• Device Lot Number: 1912766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female
• Patient Race: White