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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  
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. Some of the poly from the locking ring sheered off from the second distal femur axial pin during insertion. The surgeon pulled the second distal femur axial pin and inserted a guardian distal femur axial pin. The surgery was completed successfully. No additional information regarding this adverse event has been provided.
 
Manufacturer Narrative
Additional information was received on 01 march 2022 that identified another distal femur axial pin being involved in this event. This additional device is reported in this report. The investigation is complete. The device was not returned for evaluation. The root cause of the intraoperative distal femur axial pin issue could not be determined. The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint. If any additional information is obtained, a supplemental mdr will be filed accordingly. Multiple mdrs were submitted for this event: #3013450937-2021-00354.
 
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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 Key13653406
MDR Text Key289003059
Report Number3013450937-2022-00110
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
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25002111E
Device Catalogue Number25002111E
Device Lot Number1887355
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 Manufactured06/07/2021
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: 03/02/2022 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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