MAUDE Adverse Event Report: MAKO SURGICAL CORP. PROBE- SHARP STRAIGHT; STEREOTACTIC DEVICE, ACCESORY

Catalog Number 110810

Device Problem Bent (1059)

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

Event Date 04/04/2016

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

The surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).Before the procedure started while setting up in the or two sharp probes had bent tips and did not pass probe check.A third instrument tray was opened and successfully passed probe check.The outcome of the surgery was successful.

Manufacturer Narrative

Device identification: the reported device was confirmed to be an probe- sharp straight, p/n 110810, lot 06010113.Device history review: review of the device history records indicate (b)(4) devices were inspected and accepted into final stock on 2/27/2013, with no related nonconformances.An additional part was inspected and released on 7/22/013.Device evaluation and results: visual inspection.Visual inspection shows that the tip of the probe is bent.Dimensional inspection: dimensional inspection was not completed because the visual inspection confirmed the failure.Functional inspection: a robot was used to test the function of the probe.A probe check was completed 5 times, with the average error 1.1 mm.This is just outside an "acceptable" result (> 1 mm) and is considered "not optimal." complaint history review: a review of complaints related to p/n 110810, lot number 06010113 shows 1 additional complaints related to the failure in this investigation.It is (b)(4) and is on the same pi as the current complaint.Tracking of complaints related to the 110810 part number will be tracked through quarterly trend request #860.Conclusions: the failure mode was confirmed.The tip is bent and the probe check produced a "not optimal" result.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).Before the procedure started while setting up in the or two sharp probes had bent tips and did not pass probe check.A third instrument tray was opened and successfully passed probe check.The outcome of the surgery was successful.

• Brand Name: PROBE- SHARP STRAIGHT
• Type of Device: STEREOTACTIC DEVICE, ACCESORY
• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5567735
• MDR Text Key: 42339416
• Report Number: 3005985723-2016-00114
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• 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: 04/04/2016

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: 110810
• Device Lot Number: 06010113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• 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