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

Catalog Number	112230
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
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
Pelvic array is broken, couldn¿t screw onto pin clamp.Case type: tka.Surgical delay <= 15 minutes.
Event or Problem Description
Pelvic array is broken, couldn¿t screw onto pin clamp.Case type: tka.Surgical delay <= 15 minutes.
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.Pelvic array is broken, couldn¿t screw onto pin clamp.Case type: tka surgical delay <= 15 minutes.Product evaluation and results: product history review: a review of the device history records shows that 80 parts with this lot number were manufactured, inspected, and accepted into final stock with no non-conformances.The dates and quantities are as follows: 6/10/15 - 30, 8/6/15 - 10, 8/7/15 - 30, 8/24/15 - 10.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot #19010315 shows 3 additional complaints related to the failure in this investigation.Conclusions: the event could not be confirmed.

• 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: 9376885
• Report Number: 3005985723-2019-00844
• Device Sequence Number: 16904149
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/16/2020

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 Catalogue Number: 112230
• Device Lot Number: 19010315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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