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	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
S 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 the procedure a portion of the acetabular checkpoint remained within the pelvis.It was buried in the bone.It was not near the joint nor any other metal.It was not prominent from the bone and not irritating any soft tissues.Further debridement would have damaged the bone in order to remove." original case type: right tha with direct anterior approach with robotic arm assistance update: "cementless right total hip arthroplasty with direct anterior approach with robotic arm assistance the issue was noticed when attempt to remove the checkpoint pin; no known surgical delay.".
Event or Problem Description
Submitted through a medwatch "during the procedure a portion of the acetabular checkpoint remained within the pelvis.It was buried in the bone.It was not near the joint nor any other metal.It was not prominent from the bone and not irritating any soft tissues.Further debridement would have damaged the bone in order to remove." original case type: right tha with direct anterior approach with robotic arm assistance.Update: "cementless right total hip arthroplasty with direct anterior approach with robotic arm assistance.The issue was noticed when attempt to remove the checkpoint pin; no known surgical delay.".
Additional Manufacturer Narrative
Reported event: submitted through a medwatch "during the procedure a portion of the acetabular checkpoint remained within the pelvis.It was buried in the bone.It was not near the joint nor any other metal.It was not prominent from the bone and not irritating any soft tissues.Further debridement would have damaged the bone in order to remove." original case type: right tha with direct anterior approach with robotic arm assistance update: "cementless right total hip arthroplasty with direct anterior approach with robotic arm assistance.The issue was noticed when attempt to remove the checkpoint pin; no known surgical 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.

• 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: 9646681
• Report Number: 3005985723-2020-00057
• Device Sequence Number: 11459214
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• 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: 111653
• Device Catalogue Number: 111653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• 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: 63 YR