MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 212480

Device Problems Fracture (1260); Difficult to Insert (1316)

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

Event Date 08/10/2021

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

Damaged mako angled saw attachment affecting cuts.Cutting more than 1mm deep without showing red.Power cutting in and out.Not mics as straight attachment worked fine, and mics was recently replaced.Update 19 august 2021: distal femoral cuts were inaccurate.

Manufacturer Narrative

Reported event.An event regarding mechanical failure involving a mako saw attachment was reported.The event was confirmed.Method & results.-product evaluation and results: functional inspection confirms the event.The ratcheting (or internal gear) mechanism is broken and thus (does not allow power to be transferred to the attachment).-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 3513237, were manufactured and accepted into final stock on 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

Damaged mako angled saw attachment affecting cuts.Cutting more than 1mm deep without showing red.Power cutting in and out.Not mics as straight attachment worked fine, and mics was recently replaced.Update 19 august 2021: distal femoral cuts were inaccurate.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• 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: 12414148
• MDR Text Key: 272205440
• Report Number: 3005985723-2021-00155
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143752
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212480
• Device Catalogue Number: 212480
• Device Lot Number: LOT #35040720SN #3513237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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 Age: 68 YR
• Patient Sex: Male