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

Catalog Number	143110
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
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
During left total knee arthroplasty with robotic assist, while placing the first guidance drill pin, the tip of the pin broke off into the tibial canal.The surgeon documented the break occurred due to the pt's bone quality.Th surgeon elected to retain the small fragment as the risks of removal far outweighed the risks of retention.Fda safety report id# (b)(4).
Event or Problem Description
During left total knee arthroplasty with robotic assist, while placing the first guidance drill pin, the tip of the pin broke off into the tibial canal.The surgeon documented the break occurred due to the pt's bone quality.Th surgeon elected to retain the small fragment as the risks of removal far outweighed the risks of retention.Fda safety report id# (b) (4).
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event : during left total knee arthroplasty with robotic assist, while placing the first guidance drill pin, the tip of the pin broke off into the tibial canal.The surgeon documented the break occurred due to the pt's bone quality.Th surgeon elected to retain the small fragment as the risks of removal far outweighed the risks of retention.Fda safety report id# (b) (4).Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: review of the device history records indicate 439 devices were manufactured and accepted into final stock on 02/21/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 143110, l/n w62601-2 shows no additional complaints related to the failure in this investigation.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.¿ corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an ncs and capas associated with the product and failure mode reported in this event.This is nc 1470754 and capa 1480798.H3 other text : product was not available for evaluation.

• 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: 8603037
• Report Number: 3005985723-2019-00358
• Device Sequence Number: 2948108
• Product Code: OLO
• UDI-Device Identifier: 00848486018139
• UDI-Public: 00848486018139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 143110
• Device Lot Number: W62601-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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: Hospitalization