MAUDE Adverse Event Report: MAKO SURGICAL CORP. VARIABLE ANGLE CORTICAL SCREW, STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	111655
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
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
Tha with mako (direct anterior approach).Used enhanced workflow, so used variable cortical screw around proximal femur.Procedure was completed without any problem.Greater trochanter fracture was happened probably during rehabilitation.Sales rep was informed that 3 similar cases happened.In surgeon's opinion, this event happened due to use of variable cortical screw, but direct cause was unknown.Another possibility is that bone is thin around greater trochanter because they used anterior approach.In addition, there is a possibility that the screw may interfere many times during retraction of the femur or trial.Whether to perform revision surgery is undecided.
Event or Problem Description
Tha with mako (direct anterior approach).Used enhanced workflow, so used variable cortical screw around proximal femur.Procedure was completed without any problem.Greater trochanter fracture was happened probably during rehabilitation.Sales rep was informed that 3 similar cases happened.In surgeon's opinion, this event happened due to use of variable cortical screw, but direct cause was unknown.Another possibility is that bone is thin around greater trochanter because they used anterior approach.In addition, there is a possibility that the screw may interfere many times during retraction of the femur or trial.Whether to perform revision surgery is undecided.Direct anterior approach.
Additional Manufacturer Narrative
Reported event: tha with mako (direct anterior approach).Used enhanced workflow, so used variable cortical screw around proximal femur.Procedure was completed without any problem.Greater trochanter fracture was happened probably during rehabilitation.Sales rep was informed that 3 similar cases happened.In surgeon's opinion, this event happened due to use of variable cortical screw, but direct cause was unknown.Another possibility is that bone is thin around greater trochanter because they used anterior approach.In addition, there is a possibility that the screw may interfere many times during retraction of the femur or trial.Whether to perform revision surgery is undecided.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: product history review was not conducted as lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.H3 other text: device not returned.

• Brand Name: VARIABLE ANGLE CORTICAL SCREW, STERILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9837995
• Report Number: 3005985723-2020-00163
• Device Sequence Number: 16531823
• Product Code: OLO
• UDI-Device Identifier: 00848486017323
• UDI-Public: 00848486017323
• Combination Product (Y/N): N
• 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): 07/15/2020

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: 111655
• Device Catalogue Number: 111655
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: Other