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

Catalog Number 144140

Device Problem Material Integrity Problem (2978)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/17/2019

Event Type  Injury  

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 Description

Supracondylar fracture of femur at or near pin location at 6 weeks post-op.Case type: tka.

Manufacturer Narrative

It was reported that supracondylar fracture of femur at or near pin location at 6 weeks post- op.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: a review of the device history records could not be performed as lot number was not provided.Complaint history review: a complaint history review could not be performed as lot number was not provided.Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.¿ h3 other text : not returned.

Event Description

Supracondylar fracture of femur at or near pin location at 6 weeks post-op.Case type: tka.

• Brand Name: BONE PIN, 4MM X 140MM, STERILE 2 PACK
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8593687
• MDR Text Key: 144535048
• Report Number: 3005985723-2019-00346
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486018177
• UDI-Public: 00848486018177
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 144140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention