MAUDE Adverse Event Report: MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 212760

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 02/25/2019

Event Type  malfunction  

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 Description

During reaming, a screw from the offset reamer shaft, came loose and fell into the wound.Case type: tha.

Event Description

During reaming, a screw from the offset reamer shaft, came loose and fell into the wound.Case type: tha.

Manufacturer Narrative

The reported device was a offset cup reamer handle, p/n (b)(4) , lot 3578992, rma 268895.Inspection: visual inspection confirms missing screw from housing assembly.Refer to attachment.Product history: review of device history records indicate that 30 devices were manufactured under lot 3578992 and 0 devices were accepted into final stock on 05/23/2017.Review of qt 17-05-0089 revealed that all the part was disposition "accept per specification / use as is" on (b)(6) 2017.Non-conformance was not related to the failure alleged in this compliant.Complaint history review: a review of complaints in trackwise related to p/n (b)(4) , lot number 3578992 shows 00 additional complaints related to the failure in this investigation.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Conclusion: visual inspection confirms failure of screw disassociation.

• Brand Name: OFFSET CUP REAMER HANDLE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8392454
• MDR Text Key: 138141631
• Report Number: 3005985723-2019-00208
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032142
• UDI-Public: 00848486032142
• Combination Product (y/n): N
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212760
• Device Lot Number: 3578992
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization