MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE); STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111645
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
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
Femur checkpoint broke while being removed with pliers.Half is still in the patient , the other half was taken by a nurse.Dr (b)(6) was okay with leaving the hardware in the patient.Case type: tha.
Additional Manufacturer Narrative
Reported event: it was reported that the checkpoint broke and it was removed by revision surgery product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: product history review was not performed as the lot number was incorrect.Complaint history review: complaint history review was not performed as the lot number was product history review was not performed as the lot number was incorrect.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions 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.
Event or Problem Description
Femur checkpoint broke while being removed with pliers.Half is still in the patient , the other half was taken by a nurse.Dr kasper was okay with leaving the hardware in the patient.Case type: tha.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8306787
• Report Number: 3005985723-2019-00095
• Device Sequence Number: 986165
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• 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): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 111645
• Device Lot Number: 10252018-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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