MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

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

Event Date 06/28/2017

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

Pka/tka/tha: tka.Event description: at the end of the procedure, it was noticed the screw holding the gray handle onto the mics fell off.It was found on the floor.

Manufacturer Narrative

"reported event: it was reported that the screw holding the gray handle onto the mics fell off.Issue was noticed before case, therefor there was no case delay and no patient harm.Device history review: review of device history records indicate 14 devices were manufactured under lot k09gu and 13 including (b)(4) were accepted into final stock on 05/10/17.A review of (b)(4) revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to parts in lot number k09gu, p/n 209063 shows no other complaint related to the failure in this investigation.Visual inspection: visual inspection revealed no physical damage of unit.The screw was outside of the unit.Dimensional inspection: dimensional inspection was not completed visual inspection clearly shows the failure of the device.Functional inspection: functional inspection was not completed.Reported problem was with the screw and handle.Conclusions: the screw holds the handle in place.If the screw backs out then the handle can fall.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that (b)(4) and capa (b)(4) associated with the failure mode reported in this event.".

Event Description

Pka/tka/tha: tka.Event description: at the end of the procedure, it was noticed the screw holding the gray handle onto the mics fell off.It was found on the floor.

• Brand Name: HANDPIECE MICS
• 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: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6681776
• MDR Text Key: 78857321
• Report Number: 3005985723-2017-00281
• Device Sequence Number: 1
• Product Code: OLO
• 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: 10/08/2017

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 Catalogue Number: 209063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 10/08/2017
• 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): Hospitalization