MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 110MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	213524
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
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
Primary left mako tka.It was reported that a bone pin broke in the patient's tibia.The surgeon reported the portion in the patient's bone would not be removed as the removal would cause more harm to the patient.Surgery was completed with no delay.Patient's bone quality was "good".The rep was not present for the procedure and does not know which of the hospital's 3 robots were used.The rep may be able to obtain the operative report and post-op x-rays, but no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Primary left mako tka.It was reported that a bone pin broke in the patient's tibia.The surgeon reported the portion in the patient's bone would not be removed as the removal would cause more harm to the patient.Surgery was completed with no delay.Patient's bone quality was "good".The rep was not present for the procedure and does not know which of the hospital's 3 robots were used.The rep may be able to obtain the operative report and post-op x-rays, but no further information will be released by the hospital or surgeon.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the device history records indicate 513 devices were manufactured and accepted into final stock on 10/29/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 213524, l/n 48840618 shows no additional complaints related to the failure in this investigation.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.
Event or Problem Description
Primary left mako tka.It was reported that a bone pin broke in the patient's tibia.The surgeon reported the portion in the patient's bone would not be removed as the removal would cause more harm to the patient.Surgery was completed with no delay.Patient's bone quality was "good".The rep was not present for the procedure and does not know which of the hospital's 3 robots were used.The rep may be able to obtain the operative report and post-op x-rays, but no further information will be released by the hospital or surgeon.

• Brand Name: BONE PIN, 3.2MM X 110MM, 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: 9119596
• Report Number: 3005985723-2019-00696
• Device Sequence Number: 2347052
• Product Code: OLO
• UDI-Device Identifier: 07613327412369
• UDI-Public: 07613327412369
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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 Catalogue Number: 213524
• Device Lot Number: 48840618
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: Hospitalization
• Patient Age: 49 YR