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

Model Number	112230
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	11/06/2019
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 pelvic array when tightening.Case type: tha.Surgical delay: 2 minutes.Patient was under anesthesia.
Additional Manufacturer Narrative
Reported event: broken pelvic array when tightening.Case type: tha.Surgical delay: 2 minutes, patient was under anesthesia.Product evaluation and results: as per the image provided in the communication log the broken part of the pelvic array assembly can be confirmed.Product history review: a review of the device history records indicate (b)(4) devices were manufactured under lot 19570617 and were accepted into final stock on 09/20/2019.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot 19570617, shows 1 additional complaint related to the failure in this investigation.Pr id : (b)(4).Conclusions: the failure mode was confirmed as per the image provided in the communication log.If device and/or additional information become available, this investigation will be reopened.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 pelvic array when tightening.Case type: tha.Surgical delay: 2 minutes.Patient was under anesthesia.

• 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: 9396713
• Report Number: 3005985723-2019-00875
• Device Sequence Number: 19521011
• 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): 02/19/2020

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 Model Number: 112230
• Device Catalogue Number: 112230
• Device Lot Number: 19570617/112230
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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: Hospitalization