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

Catalog Number	111430
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Pka dr (b)(6) was tightening the array clamp onto the femoral bone pin, when the tightening mechanism snapped.The bone pins were stuck inside of the clamp and were taken out with bolt cutters and the pin driver.Surgical delay yes, 25 minutes-yes, the patient was under anesthesia.
Event or Problem Description
Pka.Dr (b)(6) was tightening the array clamp onto the femoral bone pin, when the tightening mechanism snapped.The bone pins were stuck inside of the clamp and were taken out with bolt cutters and the pin driver.Surgical delay yes, 25 minutes-yes, the patient was under anesthesia.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: dr gordon was tightening the array clamp onto the femoral bone pin, when the tightening mechanism snapped.The bone pins were stuck inside of the clamp and were taken out with bolt cutters and the pin driver.Surgical delay yes, 25 minutes-yes, the patient was under anesthesia.Product evaluation and results: visual inspection: visual inspection shows the clamp has some slight scratches on the part.No major damage was observed.Dimensional inspection dimensional inspection could not be completed since the clamp is still fully assembled.Functional inspection: functional inspection confirmed the failure.The tightening screw has been snapped between the retaining feature and the locking mechanism.This has kept the parts assembled together but prevents the user from loosening the clamp from the bone pins.The materials of the clamp were confirmed during inspection via material certifications.Product history review: review of the device history records indicate 30 devices were manufactured and accepted into final stock on 10/20/2014.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111430, lot number 19180214 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed.No additional investigation activities are required.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.

• Brand Name: DUAL PIN BASE CLAMP ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7812507
• Report Number: 3005985723-2018-00509
• Device Sequence Number: 2112571
• Product Code: OLO
• UDI-Device Identifier: 00848486002770
• UDI-Public: 00848486002770
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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
• Report Date (Section B): 02/26/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 111430
• Device Lot Number: 19180214
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 02/26/2019
• 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: Hospitalization