MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 210060

Device Problem Material Integrity Problem (2978)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2017

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

Carbon fiber is splintering and pitting.

Manufacturer Narrative

Reported event: customer reported that the carbon fiber is splintering and pitting.Device evaluation and results: device evaluation was performed and the base bar assembly event was confirmed.Device history review: review of the device history records indicate 40 devices were manufactured and inspected on 11-15-2016 and were accepted with no reported discrepancies.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the base bar assembly.There has been one other event for the referenced lot number.Pr # 1518583 - was found to be from the same lot as the part in this complaint.The part from pr # 1518583 displayed a similar failure.Conclusions: the base bar assembly shows minor signs of wear.Very small chips on the bar can be observed.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.

Event Description

Carbon fiber is splintering and pitting.

Manufacturer Narrative

"while reviewing the complaint record associated with this report, it was discovered that this event was incorrectly filed as a serious injury.We confirmed that this event did not cause or contribute to any life-threatening condition or permanent impairment to the patient and did not require any medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additionally, a review of complaint history records from (b)(6) 2016 until today, confirmed that there have been no reports of death or serious injury associated with similar events for this device family.Finally, the device¿s associated risk documentation confirmed that the highest potential severity of harm for this hazardous situation is a s2.Therefore, we will no longer be filing reports for this event type.

Event Description

Carbon fiber is splintering and pitting.

• Brand Name: BASE BAR ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 6552662
• MDR Text Key: 74696848
• Report Number: 3005985723-2017-00204
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210060
• Device Lot Number: 570101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization