MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ASSY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112230
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
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
Broken clamp on pelvic array when tightening.Case type: (b)(6).
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: it was reported that the pelvic array screw broke while tightening.Product evaluation and results: visual inspection shows screw of pelvic array assembly p/n 112230 was missing.Functional inspection cannot be completed since the pelvic array screw was not returned and visual inspection confirmed pelvic array screw was missing.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 19030315 and accepted into final stock on 07/16/ 2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot number 19030315 shows no additional complaints related to the failure in this investigation.Conclusions: the fracture of the pin could not be confirmed as the pin was not returned but it was missing from the array.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
Event or Problem Description
Broken clamp on pelvic array when tightening.Case type: (b)(4).

• Brand Name: PELVIC ARRAY ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8387244
• Report Number: 3005985723-2019-00193
• Device Sequence Number: 19375911
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/13/2019

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: 112230
• Device Lot Number: 19030315
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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