MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_PRODUCT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/22/2021

Event Type  Injury  

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 Description

During mako tka, the surgeon noticed a crack on the tibia after cutting it, but he continued procedure, then a fracture occurred at ap face when keel was punched.It was fixed by using soft wire, fixed the keel by chisel and implanted and closing the incision.The surgeon wanted to know the root casue of the event, whether it was becase mako procedure, aggressive use of kocher to pull the bone or forced pulling tibia to avoid medial exfoliation.

Manufacturer Narrative

Reported event: an event regarding intraop fracture involving an unknown guide was reported.The event was not 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: no medical records were received for review with a clinical consultant.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 exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text: device not available.

Event Description

During mako tka, the surgeon noticed a crack on the tibia after cutting it, but he continued procedure, then a fracture occurred at ap face when keel was punched.It was fixed by using soft wire, fixed the keel by chisel and implanted and closing the incision.The surgeon wanted to know the root cause of the event, whether it was because mako procedure, aggressive use of kocher to pull the bone or forced pulling tibia to avoid medial exfoliation.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_PRODUCT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11340601
• MDR Text Key: 232338074
• Report Number: 3005985723-2021-00024
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 219999
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other