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

Model Number 209063

Device Problems Loss of Power (1475); Complete Loss of Power (4015)

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

Event Date 07/22/2021

Event Type  malfunction  

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.

Event Description

Mako mics handpiece would not cut.Power to the handpiece but the saw would not oscillate and there was metal debris.New mics handpiece used.

Manufacturer Narrative

Reported event an event regarding non functional involving a mako mics was reported.The event was confirmed.Method & results product evaluation and results: handpiece mics ¿ 209063 ¿ serial# (b)(6) - rma#331104 inspected and determined failure of the following test steps: 7.1.5.1 original cable agitation test 7.1.5.3.4 tn 0835 cable functional (new cable) original description confirmed.Disposition: rtv - motor failure inspected by: spencer barfield 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 confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Mako mics handpiece would not cut.Power to the handpiece but the saw would not oscillate and there was metal debris.New mics handpiece used.

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12325571
• MDR Text Key: 266702103
• Report Number: 3005985723-2021-00141
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: 42040219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male