MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

As part of 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 Description

While resecting the distal femur, the collar on the mics hand piece became unattached due to a broken screw.We were able to switch hand pieces and re register and continue the surgery to completion.There was a 2 min delay just for changing the hand piece.Tka.

Manufacturer Narrative

Reported event: it was reported that the handpeice had a broken screw and fell apart.Issue was noticed during case, therefor there was a 2 minute case delay and no patient harm.Device history review: device history records indicate 25 devices were manufactured under lot k08cd and 23 including 4201095 were accepted into final stock on 9/21/16.A review of (b)(4) revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to parts in lot number k08cd, p/n 209063 shows no other complaint related to the failure in this investigation."visual inspection: visual inspection revealed no physical damage of unit.Two screws backed out of the unit and a third screw broke.See attached pictures.Each of the backed out screws had evidence of loctite (as shown next to the part in the pictures).The broken screw had a fatigue fracture.Dimensional inspection: dimensional inspection was not completed visual inspection clearly shows the failure of the device.Functional inspection: the handpiece motor and electronics function as intended.Material analysis: material analysis was not completed because functional inspection clearly showed failure." conclusions: the screws hold the front end in place.If the screws back out then the front will come off.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that (b)(4) and capa (b)(4) are associated with the failure mode reported in this event.

Event Description

While resecting the distal femur, the collar on the mics hand piece became unattached due to a broken screw.We were able to switch hand pieces and re register and continue the surgery to completion.There was a 2 min delay just for changing the hand piece.Tka.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6898404
• MDR Text Key: 89407328
• Report Number: 3005985723-2017-00465
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization