MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIGH SPEED ROTARY ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 204990

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

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

Part is leaking fluid.Patient was not under anesthesia.Case type: pka (mics).

Manufacturer Narrative

Reported issue -part is leaking fluid.Patient was not under anesthesia.Case type: pka (mics).Product inspection ¿ product inspection was not performed as product was not returned for inspection.Product history review ¿ review of the device history records indicates 81 devices were manufactured under p/n 204990, lot 40m083940 and all devices were accepted into final stock on 05/06/2020, including (b)(6) with no reported discrepancies.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 204990, l/n 40m083940 shows 00 additional complaints related to the failure in this investigation.Nc/capa history review - a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.Conclusion ¿ the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.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.No additional investigation or specific actions are required.H3 other text : device not returned.

Event Description

Part is leaking fluid.Patient was not under anesthesia.Case type: pka (mics).

• Brand Name: HIGH SPEED ROTARY ATTACHMENT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10396145
• MDR Text Key: 202553362
• Report Number: 3005985723-2020-00253
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486021849
• UDI-Public: 00848486021849
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204990
• Device Catalogue Number: 204990
• Device Lot Number: 4002673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other