MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Model Number	143140
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	01/27/2020
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
During surgery using the mako total knee system, a pin (3.2 mm x 140 mm) was inserted using a hospital-owned handpiece / pin collet to install an array on the femur side.The inner cortical bone was perforated without any problem, but the pin stopped moving when it came into contact with the outer cortical bone.When the surgeon removed the pin collet and manually checked the pin's fixation, he determined that it was sufficient to fix the array and continued the operation.When the pin was removed after the implant was installed, the nurse noticed a break in the tip of the pin, and when confirmed by x-ray after the operation, a metal piece of about 3 mm was found outside the diaphysis.The operation is completed without removal at the discretion of the doctor.
Event or Problem Description
During surgery using the mako total knee system, a pin (3.2 mm x 140 mm) was inserted using a hospital-owned handpiece / pin collet to install an array on the femur side.The inner cortical bone was perforated without any problem, but the pin stopped moving when it came into contact with the outer cortical bone.When the surgeon removed the pin collet and manually checked the pin's fixation, he determined that it was sufficient to fix the array and continued the operation.When the pin was removed after the implant was installed, the nurse noticed a break in the tip of the pin, and when confirmed by x-ray after the operation, a metal piece of about 3 mm was found outside the diaphysis.The operation is completed without removal at the discretion of the doctor.
Additional Manufacturer Narrative
Updated b2.Reported event: during surgery using the mako total knee system, a pin (3.2 mm x 140 mm) was inserted using a hospital-owned handpiece / pin collet to install an array on the femur side.The inner cortical bone was perforated without any problem, but the pin stopped moving when it came into contact with the outer cortical bone.When the surgeon removed the pin collet and manually checked the pin's fixation, he determined that it was sufficient to fix the array and continued the operation.When the pin was removed after the implant was installed, the nurse noticed a break in the tip of the pin, and when confirmed by x-ray after the operation, a metal piece of about 3 mm was found outside the diaphysis.The operation is completed without removal at the discretion of the doctor.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the product history records cannot be conducted as the lot number is unknown.Complaint history review: review of the complaint history records cannot be conducted as the lot number is unknown.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.

• Brand Name: BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9749565
• Report Number: 3005985723-2020-00096
• Device Sequence Number: 3086786
• Product Code: OLO
• UDI-Device Identifier: 00848486018146
• UDI-Public: 00848486018146
• Combination Product (Y/N): N
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 143140
• Device Catalogue Number: 143140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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; Other