MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; STEREOTAXIC DEVICE, ROBOTICS

Model Number	111653
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
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
The customer reported that during a robotic left hip the surgeon was screwing in the checkpoint for the robot.The stem of the checkpoint snapped and the tip has been left inside the patient's left pelvis / acetabula.The surgeon left the piece in situ as removing it wold have caused more damage to the patient.The piece is flush to the bone and there is no metal visible.
Additional Manufacturer Narrative
Update to b2.Reported event: the customer reported that during a robotic left hip the surgeon was screwing in the checkpoint for the robot.The stem of the checkpoint snapped and the tip has been left inside the patient's left pelvis / acetabula.The surgeon left the piece in situ as removing it wold have caused more damage to the patient.The piece is flush to the bone and there is no metal visible.**update** 2 minute surgical delay case completed utilising a 3.5mm x15mm hex screw.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records indicate 800 devices were manufactured and accepted into final stock on 10/02/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111653, l/n w65972-2 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc¿s associated with the product and failure mode reported in this event h3 other text : device not returned.
Event or Problem Description
The customer reported that during a robotic left hip the surgeon was screwing in the checkpoint for the robot.The stem of the checkpoint snapped and the tip has been left inside the patient's left pelvis / acetabula.The surgeon left the piece in situ as removing it wold have caused more damage to the patient.The piece is flush to the bone and there is no metal visible.

• Brand Name: CHECKPOINT, 3.5 HEX IMPACTION STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9758245
• Report Number: 3005985723-2020-00109
• Device Sequence Number: 2806827
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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 Model Number: 111653
• Device Catalogue Number: 111653
• Device Lot Number: W65972-2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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