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

Model Number 210070

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

Patient Problem Tissue Damage (2104)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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

Splintering in the black leg holder has occurred and gave employee in cpd splinters (carbon fiber) that has caused concern as to the structural integrity of the device and if further splintering could occur in the or and affect the patient.Would like all carbon pieces replaced (creating individual complaints per piece).Case type: (b)(4).Patient was under anesthesia.

Manufacturer Narrative

Splintering in the black leg holder has occurred and gave employee in cpd splinters (carbon fiber) that has caused concern as to the structural integrity of the device and if further splintering could occur in the or and affect the patient.Would like all carbon pieces replaced (creating individual complaints per piece).Case type: tka.Patient was under anesthesia.Product evaluation and results: functional inspection: tested for carbon fiber splinters, no known issue found on bar extension.Product history review: review of the device history records indicate (b)(4) were manufactured and (b)(4) were accepted into final stock on 11/11/2017.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 in catsweb and trackwise related to p/n 206693, lot number 608499, shows 01 additional complaints related to the failure in this investigation.Complaint.Conclusions: the event could not be confirmed.

Event Description

Splintering in the black leg holder has occurred and gave employee in cpd splinters (carbon fiber) that has caused concern as to the structural integrity of the device and if further splintering could occur in the or and affect the patient.Would like all carbon pieces replaced (creating individual complaints per piece).Case type: tka.Patient was under anesthesia.

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

Splintering in the black leg holder has occurred and gave employee in cpd splinters (carbon fiber) that has caused concern as to the structural integrity of the device and if further splintering could occur in the or and affect the patient.Would like all carbon pieces replaced (creating individual complaints per piece).Case type: tka.Patient was under anesthesia.

• Brand Name: BAR EXTENSION
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9141691
• MDR Text Key: 161063478
• Report Number: 3005985723-2019-00709
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (y/n): N
• 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: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 210070
• Device Catalogue Number: 210070
• Device Lot Number: 608499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other