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

Model Number 212480

Device Problems Residue After Decontamination (2325); Noise, Audible (3273); Intermittent Loss of Power (4016)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

The following was reported: mako mics handpiece became loud during surgery.Towards the end of the last cut, the sawing function of the handpiece failed.Black debris formed inside the handpiece and saw blade attachment.In addition, the straight saw blade attachment became very hot.Last cut had to be finished with a manual saw.Case type: 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.Device not returned.

Event Description

The following was reported: mako mics handpiece became loud during surgery.Towards the end of the last cut, the sawing function of the handpiece failed.Black debris formed inside the handpiece and saw blade attachment.In addition, the straight saw blade attachment became very hot.Last cut had to be finished with a manual saw.Case type: tka.

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: visual inspection did not confirm black debris, but functional verification confirmed that the gears in intake shaft were not rotating smoothly; thus causing saw attachment to not function.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events 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.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14302815
• MDR Text Key: 290964676
• Report Number: 3005985723-2022-00052
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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: 35011020 / 3514594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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