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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 212480
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Event Description
Mics screw at bottom of grey handle fell out during cutting. Distal cut was checked with planar probe and was 1 mm proud after 3 recuts and red showing throughout cut. Surgical delay
=
15 minutes. Case type / application: tka.
 
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.
 
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Brand Name2.7 DEGREE ANGLED SAGITAL SAW
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key13975128
MDR Text Key288357322
Report Number3005985723-2022-00042
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number212480
Device Catalogue Number212480
Device Lot Number35081119 / 3509688
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2022
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? No
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: 04/01/2022 Patient Sequence Number: 1
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