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

Catalog Number	144140
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/17/2019
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
Supracondylar fracture of femur at or near pin location at 6 weeks post-op.Case type: tka.
Additional 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 or Problem 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
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8593687
• Report Number: 3005985723-2019-00346
• Device Sequence Number: 2074943
• Product Code: OLO
• UDI-Device Identifier: 00848486018177
• UDI-Public: 00848486018177
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 11/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 144140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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