MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTAXIC DEVICE, ROBOTICS

Model Number	206270
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
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
Mako total hip cup impactor pad broken on removal from end effector/impactor post cup impaction.Cup impaction completed before issue and no replacement needed.Male patient undergoing total hip arthroplasty.
Additional Manufacturer Narrative
Reported event: it was reported that mako total hip cup impactor pad broken on removal from end effector/impactor post cup impaction.Cup impaction completed before issue and no replacement needed.Male patient undergoing total hip arthroplasty.Product evaluation and results: 1.Three communication attempts were made and appropriate information was not received.Product was not returned.2.The photos provided by the complainant during the complaint intake confirms the alleged failure of cup impactor pad broken.Product history review: not performed as the lot number is not reported.Complaint history review: not performed as the lot number is not reported.Conclusions: the failure is confirmed by the photos provided by the complainant during the complaint intake.No additional investigation or specific actions are required.If additional information is received, then the complaint 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.H3 other text : device not returned.
Event or Problem Description
Mako total hip cup impactor pad broken on removal from end effector/impactor post cup impaction.Cup impaction completed before issue and no replacement needed.Male patient undergoing total hip arthroplasty.

• Brand Name: SHELL IMPACTION PLATFORM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9378109
• Report Number: 3005985723-2019-00846
• Device Sequence Number: 374864
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 206270
• Device Catalogue Number: 206270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 03/26/2020
• 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