MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5MM HEX X 15MM, STERILE; STEREOTAXIC DEVICE, ROBOTICS

Model Number	116230
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	04/01/2019
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
Submitted through a medwatch "during a cementless right tha with robotic arm assistance through direct anterior approach the mako checkpoint pin broke during removal.When the pin was removed the head of the checkpoint came out and the nail portion stayed in the pelvic bone." original case type: cementless right tha with robotic arm assistance through direct anterior approach, fluoroscopic assistance for right hip primary osteoarthritis.Update: "surgery date and procedure: (b)(6) 2019, cementless right total hip arthroplasty with robotic arm assistance through direct anterior approach, fluoroscopic assistance there was no known delay.".
Additional Manufacturer Narrative
Reported event: submitted through a medwatch "during a cementless right tha with robotic arm assistance through direct anterior approach the mako checkpoint pin broke during removal.When the pin was removed the head of the checkpoint came out and the nail portion stayed in the pelvic bone." original case type: cementless right tha with robotic arm assistance through direct anterior approach, fluoroscopic assistance for right hip primary osteoarthritis.Update: "surgery date and procedure: (b)(6) 2019, cementless right total hip arthroplasty with robotic arm assistance through direct anterior approach, fluoroscopic assistance there was no known delay." product evaluation and results: as per the image provided in the communication log the broken checkpoint cannot be determined.Also the device has not been returned for further investigation.Product history review: review of the device history records could not be conducted as the lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.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
Submitted through a medwatch "during a cementless right tha with robotic arm assistance through direct anterior approach the mako checkpoint pin broke during removal.When the pin was removed the head of the checkpoint came out and the nail portion stayed in the pelvic bone." original case type: cementless right tha with robotic arm assistance through direct anterior approach, fluoroscopic assistance for right hip primary osteoarthri tis.Update: "¿ surgery date and procedure: (b)(6) 2019 , cementless right total hip arthroplast y with robotic arm assistance through direct anterior approach, fluoroscopi c assistance ¿ there was no known delay.".

• Brand Name: CHECKPOINT, 3.5MM HEX X 15MM, STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9646678
• Report Number: 3005985723-2020-00063
• Device Sequence Number: 14306427
• Product Code: OLO
• UDI-Device Identifier: 00848486002978
• UDI-Public: 00848486002978
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 116230
• Device Catalogue Number: 116230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 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: Hospitalization
• Patient Age: 73 YR