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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 212760
Device Problems Device Difficult to Setup or Prepare (1487); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Upon reaming the acetabulum, it was determined that the offset reamer shaft handle was not sliding into the hip end effector. We were able to force the handle into the end effector; however, it was sticking to the walls of the hip end effector. The surgeon was able to ream and impact the acetabular cup; however, he complained that it was not working properly. There was a 2 min. Delay and no other issues with the case.
 
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Brand NameOFFSET CUP REAMER HANDLE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8148490
MDR Text Key129836264
Report Number3005985723-2018-00729
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number212760
Device Lot Number3761474
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/10/2018 Patient Sequence Number: 1
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