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

Model Number	210070
Medical Device Problem Codes	Material Frayed (1262); Material Integrity Problem (2978)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9141691
• Report Number: 3005985723-2019-00709
• Device Sequence Number: 19288915
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/28/2019; 04/13/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/23/2019; 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other