MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

Power cutting out on anterior cut.On and off the bone.Case type / application: tka.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.Serial specific voluntary recall was initiated for the mako integrated cutting system (mics) within scope of a capa.The initial root cause analysis determined that the process for characterizing mics handpieces for specific serial numbers deviated from its qualified state at the time of validation.The capa investigation is currently in progress and an updated communication will be submitted upon completion of the investigation.

Manufacturer Narrative

Correction: upon further review it was noted that this event does not meet the criteria of a reportable event.Although the serial number is in scope of serial specific voluntary recall; (b)(4), the reported failure mode is not in scope of the recall.This event is covered under total knee arthroplasty mako system (b)(6) under hazardous situation " system experiences unrecoverable malfunction".Reported event: an event regarding non functional involving a mako mics 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, including serial number (b)(6), were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been 1 other similar event for the lot referenced.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 Description

Power cutting out on anterior cut.On and off the bone.Case type / application: tka.

Manufacturer Narrative

Upon further review it has been determined that this event is not reportable.The awareness date of this event is after this device was received and repaired by the manufacturer, which makes this event out of scope of recall z-0472-2021; therefore, this mdr is being cancelled.The event is covered under the total knee arthroplasty mako system risk table, hazardous situation ¿user is not provided adequate indication for registration confirmation¿ that the highest potential severity of harm is s1.

Event Description

Power cutting out on anterior cut.On and off the bone.Case type / application: tka.

• Brand Name: HANDPIECE MICS
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 14454820
• MDR Text Key: 292491235
• Report Number: 3005985723-2022-00060
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: LOT:42060520/SN:4209389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 07/18/2022; 04/26/2023
• Supplement Dates FDA Received: 08/12/2022; 04/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0472-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other