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

Catalog Number	111651
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
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
Surgeon commented that the greater trochanter fractured through the insertion site of the proximal checkpoint during the joint reduction with stem implant and trial head during mako direct anterior approach tha.The surgeon also commented that he did not believe that the checkpoint caused the fracture.The fracture was repaired with a cerclage cable.Case type: tha.
Additional Manufacturer Narrative
Surgeon commented that the greater trochanter fractured through the insertion site of the proximal checkpoint during the joint reduction with stem implant and trial head during mako direct anterior approach tha.The surgeon also commented that he did not believe that the checkpoint caused the fracture.The fracture was repaired with a cerclage cable 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 not provided.Complaint history review: complaint history review was not performed as the lot number was not provided.Conclusions: the failure could not be determined 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.
Event or Problem Description
Surgeon commented that the greater trochanter fractured through the insertion site of the proximal checkpoint during the joint reduction with stem implant and trial head during mako direct anterior approach tha.The surgeon also commented that he did not believe that the checkpoint caused the fracture.The fracture was repaired with a cerclage cable.Case type: tha.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8485717
• Report Number: 3005985723-2019-00278
• Device Sequence Number: 1928182
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 12/09/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 111651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 56