MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209063

Device Problems Failure to Calibrate (2440); Intermittent Loss of Power (4016)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Not passing registration.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.Device evaluated by mfr.Device not returned.

Manufacturer Narrative

Reported event an event regarding registration fails involving a mako mics was reported.The event was confirmed.Method & results the failure is confirmed as it is under the scope of nc : mics characterization process deviated from the qualified state.Product evaluation and results: handpiece mics ¿ 209063 ¿ serial# (b)(6).Inspected and determined failure of the following test steps: 7.1.1 cable visual inspection - pass 7.1.2 hand piece visual inspection - pass 7.1.3 pivot handle lock test - pass 7.1.4 collar test - pass 7.1.5.1 original cable agitation test - pass disposition: rtv 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 other complaints with a similar failure mode for this lot.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.Corrective action/preventive action: 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.

Event Description

Not passing registration.Case type / application: tka.

Event Description

Not passing registration.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.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• 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: kelsey williams ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15270234
• MDR Text Key: 301010915
• Report Number: 3005985723-2022-00111
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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: 42020720 / 4209795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2020
• 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