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

Model Number 212480

Device Problems Display or Visual Feedback Problem (1184); Device Slipped (1584)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Mics screw at bottom of grey handle fell out during cutting.Distal cut was checked with planar probe and was 1 mm proud after 3 recuts and red showing throughout cut.Surgical delay = 15 minutes.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.

Event Description

Mics screw at bottom of grey handle fell out during cutting.Distal cut was checked with planar probe and was 1 mm proud after 3 recuts and red showing throughout cut.Surgical delay = 15 minutes.Case type / application: tka.

Manufacturer Narrative

Reported event: an event regarding locking mechanism 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 the blade to tighten down properly on the saw).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 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.

• 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: 13975128
• MDR Text Key: 288357322
• Report Number: 3005985723-2022-00042
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 35081119 / 3509688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2019
• 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