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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS DISTAL FEMUR AXIAL PIN

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ONKOS SURGICAL ELEOS DISTAL FEMUR AXIAL PIN Back to Search Results
Model Number 25002111E
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/02/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is in process. When the investigation is complete, a supplemental mdr will be submitted accordingly.
 
Event Description
It was reported that there was an intraoperative issue during a surgery on (b)(6) 2021. When the surgeon inserted the distal femur axial pin, some of the poly from the locking ring sheered off. The surgeon pulled the distal femur axial pin back out and inserted a new distal femur axial pin. Attempts have been made and no further information has been provided.
 
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Brand NameELEOS
Type of DeviceDISTAL FEMUR AXIAL PIN
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline road
arlington TN 38002
Manufacturer Contact
sara dailey
77 east halsey road
parsippany, NJ 07054
MDR Report Key13122527
MDR Text Key284122195
Report Number3013450937-2021-00354
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25002111E
Device Catalogue Number25002111E
Device Lot Number1885109
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25000013E, ELEOS CEMENTED SEGMENTAL STEM; P/N 25001216E, ELEOS TIBIAL POLY SPACER; P/N 25002203E, ELEOS TIBIAL BASEPLATE; P/N KSP13140E, ELEOS CANAL-FILLING STEM EXTENSION; P/N KTAGB310E, ELEOS TIBIAL BLOCK AUGMENT (2); P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
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