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

Model Number 212186

Device Problem Residue After Decontamination (2325)

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

Event Date 07/27/2022

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

Oil seems to be leaking from the back/broken o-ring.Case type / application: tka.

Manufacturer Narrative

Reported event.An event regarding foreign matter involving a mako saw attachment was reported.The event was confirmed.Method & results.-product evaluation and results: visual inspection confirms the reported event.Black substance is present on the inlet shaft of the saw attachment.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a product history review is not required, as no manufacturing specific issue has been alleged.At stryker joint replacement all devices/product are manufactured through validated equipment and inspected by trained representatives through stryker¿s quality management system.-complaint history review: a complaint history review and trend detection is not required as this is a pm.Conclusions: 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 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

Oil seems to be leaking from the back/broken o-ring.Case type / application: tka.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15270233
• MDR Text Key: 301257285
• Report Number: 3005985723-2022-00110
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212186
• Device Catalogue Number: 212186
• Device Lot Number: 35030419 / 3506455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2022
• 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