MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 4MM X 140MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Model Number	144140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/11/2023
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
One of my surgeons told me that one of his patients had a femoral fracture near the site of a pin placed for a primary mako knee.The fracture did not occur intraoperatively.The surgeon said the post op x-ray showed no fracture.The patient reported rolling over in bed, feeling a "pop", and going into the er to find she had a fractured femur.Case type/procedure: left tka.Per response: "the case was a tka.No revision was done.The femur was reduced and plated by another surgeon.".
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a mako bone pins was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: this patient sustained a postoperative fracture at or near a pin track used for mako guidance during a primary cemented cruciate retaining total knee.The root cause of this event cannot be determined with certainty.Causes of postoperative distal femoral fracture above a cemented total knee arthroplasty are multifactorial including surgical technique, patient activity level and bmi.In this case it is quite possible that the fracture occurred through a pin track but without an operation report describing the exact origin and location of the fracture it is impossible to determine this with certainty.I would not assign any causality to the implant itself.Fractures through pin tracks are a well-recognized postoperative complication.Inaccurate placement of the pin, for example, compromising more of the cortex than ideal, can contribute.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the alleged failure mode was confirmed through a clinician review, however the root cause could not be determined without additional information such as surgical notes and an operation report.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
One of my surgeons told me that one of his patients had a femoral fracture near the site of a pin placed for a primary mako knee.The fracture did not occur intraoperatively.The surgeon said the post op x-ray showed no fracture.The patient reported rolling over in bed, feeling a "pop", and going into the er to find she had a fractured femur.Case type/procedure: left tka.Per response: "the case was a tka.No revision was done.The femur was reduced and plated by another surgeon.".

• Brand Name: BONE PIN, 4MM X 140MM, STERILE 2 PACK
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16342552
• Report Number: 3005985723-2023-00029
• Device Sequence Number: 17860767
• Product Code: OLO
• UDI-Device Identifier: 00848486018177
• UDI-Public: 00848486018177
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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 Model Number: 144140
• Device Catalogue Number: 144140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White