MAUDE Adverse Event Report: MAKO SURGICAL CORP. SQUARE DRILL ADAPTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111120
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
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
Surgeon was taking out tibia bone pins and metal piece fell out of drill.Once we inspected the drill we saw the metal side on drill had broken.Case type: tka.
Additional Manufacturer Narrative
Reported event: it was reported that surgeon was taking out tibia bone pins and metal piece fell out of drill.Once we inspected the drill we saw the metal side on drill had broken product evaluation and results: from image provided: the square drill adaptor showed one of the prongs for holding the pins broken off.Product history review: review of the product history records indicate 165 devices were manufactured under lot no 06070717 and accepted into final stock on (b)(6) 2017 via qt17- 07-0080.Review of qt17-07-0080 revealed that the nonconformance is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063 lot number 06070717 shows no additional complaints related to the failure in this investigation.Conclusions: as per attached picture the alleged failure mode was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc¿s associated with the product and failure mode reported in this event.
Event or Problem Description
Surgeon was taking out tibia bone pins and metal piece fell out of drill.Once we inspected the drill we saw the metal side on drill had broken.Case type: tka.Update: "the patient was under anesthesia.".

• Brand Name: SQUARE DRILL ADAPTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8871150
• Report Number: 3005985723-2019-00562
• Device Sequence Number: 335219
• Product Code: OLO
• UDI-Device Identifier: 00848486002725
• UDI-Public: 00848486002725
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 10/23/2019

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: 111120
• Device Lot Number: 06070717
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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