MAUDE Adverse Event Report: MAKO SURGICAL CORP. SLED ASSEMBLY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	210110
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event: an event regarding locking mechanism failure involving a mako leg holder was reported.The event was not confirmed because the product was not available for inspection.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
The blue handle would not tighten causing the leg to be unstable case type / application: tka.Per response: "the blue knob would not tighten, and the patient's leg externally rotated off the table.".
Additional Manufacturer Narrative
Reported event.An event regarding locking mechanism failure involving a mako leg holder was reported.The event was not confirmed.Method & results.-product evaluation and results: functional inspection did not confirm the reported event.Sled assembly ball joint functions as intended, device functions as intended.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
The blue handle would not tighten causing the leg to be unstable case type / application: tka.Per response: "the blue knob would not tighten, and the patient's leg externally rotated off the table." additional information 6/27/2023: did the patient¿s leg fall off the table? no, the blue knob was not tightening down which allowed the leg to be unstable and rotate.
Additional Manufacturer Narrative
Rreported event an event regarding locking mechanism failure involving a mako leg holder was reported.The event was not confirmed.Method & results product evaluation and results: functional inspection did not confirm the reported event.Sled assembly ball joint functions as intended, device functions as intended.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
The blue handle would not tighten causing the leg to be unstable case type / application: tka.Per response: "the blue knob would not tighten, and the patient's leg externally rotated off the table." additional information 6/27/2023: did the patient¿s leg fall off the table? no, the blue knob was not tightening down which allowed the leg to be unstable and rotate.

• Brand Name: SLED ASSEMBLY
• 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: marisol santiago ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17140224
• Report Number: 3005985723-2023-00108
• Device Sequence Number: 1907852
• Product Code: OLO
• UDI-Device Identifier: 00848486031848
• UDI-Public: 00848486031848
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2023

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 Model Number: 210110
• Device Catalogue Number: 210110
• Device Lot Number: 19630618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 11/21/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/18/2023; 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown