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

Model Number	111653
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
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
When dr.(b)(6) pulled the impaction checkpoint out of the pelvis, a small tip of it broke off and was left in the patient.Dr.(b)(6) decided to leave it and declared no concern for the patient.Case type: tha.
Additional Manufacturer Narrative
Reported event: when the doctor pulled the impaction checkpoint out of the pelvis, a small tip of it broke off and was left in the patient.The doctor decided to leave it and declared no concern for the patient.Product evaluation and results: as per the image provided in the communication log , the broken checkpoint can be seen and determined.Product history review: (b)(4) review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 11/26/2019.No non- conformances were identified during inspection.(b)(4) -review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 09/30/2019.No non- conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111653, lot number w65974-1 shows 0 additional complaints related to the failure in this investigation.A review of complaints in catsweb and trackwise related to p/n 111653, lot number w65975-1 shows 0 additional complaints related to the failure in this investigation.Conclusions: the failure mode could be determined via visual inspection of the image provided in the communication log.If device and/or additional information become available, this investigation 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.
Event or Problem Description
When dr.(b)(6) pulled the impaction checkpoint out of the pelvis, a small tip of it broke off and was left in the patient.Dr.(b)(6) decided to leave it and declared no concern for the patient.Case type: tha.

• 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: 9711078
• Report Number: 3005985723-2020-00089
• Device Sequence Number: 2353187
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/21/2020

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: 01/22/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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