MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 212186

Device Problems Break (1069); Premature Separation (4045)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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

Straight saw attachment broke during lab.(cadaver lab).Case type: tka.As per service max: this is a clinical unit.

Event Description

Straight saw attachment broke during lab.(cadaver lab).Case type: tka.As per service max: this is a clinical unit.

Manufacturer Narrative

Follow-up #1 and final report submitted.It was reported that straight saw attachment broke during lab.(cadaver lab).Product evaluation and results: visual inspection: the 212186 2.7 degree straight sagital saw shows no wear or and tear.A picture of the device is attached.Functional inspection: the 212186 straight saw (lot: 35060219 / serial: (b)(6) easily locked into in a known good 209063 mics handpiece.A known good 116170 standard 2mm blade was installed in the 212186 straight saw; the locking knob turns normally with the clicking feeling associated with the ratcheting pawl locking.The mics was powered on and the blade swung normally.A picture of the device installed in a mics is attached.The failure mode ¿straight saw attachment broke during lab¿ was not confirmed.Dimensional inspection: not performed as no dimensional failure is alleged.Material analysis: not performed as no material failure is alleged.Product history review: 1.Review of the device history records indicate 29 devices were manufactured and all were accepted into final stock on 03-13-2019 with no reported discrepancies.2.Review of the device history records indicate 09 devices were manufactured and all were accepted into final stock on 03-11-2019 with no reported discrepancies.3.Review of the device history records indicate 10 devices were manufactured and all were accepted into final stock on 03-05-2019 with no reported discrepancies.4.Review of the device history records indicate 2 devices were manufactured and all were accepted into final stock on 03-08-2019 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 212186, lot: 35060219 shows 0 additional complaints related to the failure in this investigation.Conclusions: per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The failure was not confirmed via visual and functional inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8946569
• MDR Text Key: 156021027
• Report Number: 3005985723-2019-00612
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212186
• Device Lot Number: 35060219 / 3505774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization