MAUDE Adverse Event Report: MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 212760

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Reamer handle and end effector jammed together.Cannot be separated.

Manufacturer Narrative

This event was reported in error.A mdr does not need to be filed as the malfunction does not meet ccd 076 rev 2 criteria that states a mdr will be filed if there is ¿potential for serious injury due to instrument unavailability, or instrument fragments in wound site¿.The issue was noticed before the case and thus did not impact the patient or the case.

Event Description

Reamer handle and end effector jammed together.Cannot be separated.

• Brand Name: OFFSET CUP REAMER HANDLE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8091405
• MDR Text Key: 127953342
• Report Number: 3005985723-2018-00688
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• 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: 3578691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other