MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR, VARIABLE ANGLE; STEREOTAXIC DEVICE, ROBOTICS

Model Number	206967
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
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
After impacting the prosthesis, the surgical nurse noticed that a ball bearing of the hip end effector was lying on the floor.In order to exclude that further metal parts remained in the patient, an additional x-ray picture was made.No replacement device was used.Update: "5 minutes surgical delay.".
Event or Problem Description
After impacting the prosthesis, the surgical nurse noticed that a ball bearing of the hip end effector was lying on the floor.In order to exclude that further metal parts remained in the patient, an additional x-ray picture was made.No replacement device was used.Update: "5 minutes surgical delay.".
Additional Manufacturer Narrative
Reported event: it was reported that after impacting the prosthesis, the surgical nurse noticed that a ball bearing of the hip end effector was lying on the floor.In order to exclude that further metal parts remained in the patient, an additional x-ray picture was made.No replacement device was used.Update: "5 minutes surgical delay." product evaluation and results: visual inspection: the hip chuck slide assembly which holds the ball bearing was broken inside.Product history review: review of the device history records indicate (b)(4) devices were manufactured and (b)(4) were accepted into final stock (including serial (b)(6)) on 06-09-2019 with no reported discrepancies.A review of qt 19-07-0030 revealed that the 9 rejected devices were re-inspected and accepted into final stock on 09-11-2019.The non conformance 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 206967, lot 19241118 shows 0 additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via inspection.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 an ncs and capas associated with the product and failure mode reported in this event.This is nc 1414603 and capa 1450905.

• Brand Name: HIP END EFFECTOR, VARIABLE ANGLE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9299108
• Report Number: 3005985723-2019-00797
• Device Sequence Number: 16690217
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• 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: Nurse
• 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: 206967
• Device Catalogue Number: 206967
• Device Lot Number: 1904611
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 03/08/2020
• Initial Report FDA Received Date: 11/08/2019
• 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