MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT 3.5MM HEX X 15MM STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	116230
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During reaming with mako, the bone was too hard to cut.Manual reaming was performed using the handpiece mics.Subsequently, the check pin dislodged during the procedure.Postoperatively, the check pin was examined and found to have a worn tip.Additionally, upon inspection of the reamed bone postoperatively, powder-like particles resembling metal fragments were observed.Update: why was manual reaming performed? was the device causing any issues? the patient¿s bone quality was hard.Was there any powder like particles observed actually as the adverse consequences mention that there were no particles post x ray was done?: yes.Upon examining the reamed bone, powdery material believed to be metal fragments was observed.Why was a bone graft performed? was it due to device causing issues?: it was normal procedure.It is not related the event.
Additional Manufacturer Narrative
Reported event.An event regarding crack/fracture involving a mako checkpoint was reported.The event was confirmed.Method & results.Product evaluation and results: visual inspection confirms the event.The tip of checkpoint is broken.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the lot details were not provided.Complaint history review: could not be performed as the lot details were not provided.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: CHECKPOINT 3.5MM HEX X 15MM 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23665490
• Report Number: 3005985723-2025-00554
• Device Sequence Number: 21044178
• Product Code: OLO
• UDI-Device Identifier: 00848486002978
• UDI-Public: 00848486002978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 116230
• 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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 02/06/2026
• 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