MAUDE Adverse Event Report: MAKO Surgical Corp. REAMER HANDLE OFFSET; Orthopedic Stereotaxic Instrument

Catalog Number	212760
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sweep of spd.Case type/application: no, associated procedure.Update on 08/13/2026: screws missing from device.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding disassociation involving a mako reamer handle was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection performed.Screws missing from device.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a product history review is not required, as no manufacturing specific issue has been alleged.Complaint history review: a complaint history review is not required as there was no patient involvement.Conclusions: no patient was involved and no actual or potential patient harm existed for the alleged event.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.
Additional Manufacturer Narrative
An event regarding disassociation involving a mako reamer handle was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection performed.Screws missing from device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a product history review is not required, as no manufacturing specific issue has been alleged.-complaint history review: a complaint history review is not required as there was no patient involvement.Conclusions: no patient was involved and no actual or potential patient harm existed for the alleged event.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.

• Brand Name: REAMER HANDLE OFFSET
• 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50732543
• Report Number: 3005985723-2026-00486
• Device Sequence Number: 10586885
• Product Code: OLO
• UDI-Device Identifier: 00848486032142
• UDI-Public: 00848486032142
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K170593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 212760
• Device Lot Number: 5912731
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/11/2026
• 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: Unknown