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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT

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PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT Back to Search Results
Model Number P40-002-0275-S
Device Problems Break (1069); Positioning Problem (3009)
Patient Problem Insufficient Information (4580)
Event Date 05/18/2018
Event Type  malfunction  
Manufacturer Narrative
Identifying information, such as the lot number of the device was not reported to paragon 28.Case information including related patient information was not provided by the initial reporter.The device history record was reviewed and met all material specifications with no deviation identified.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
It was reported that the patient underwent a surgical procedure that utilized paragon 28 hammertube system on (b)(6) 2018.The angled hammertube implant was reported broken intra-operatively.It was reported that the surgeon experienced difficulty putting the implant into the proximal phalanx and tamp the implant until the plasma spray was inside the canal.The initial reporter believed the device was far enough however, the implant broke with one additional tamp.
 
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Brand Name
HAMMERTUBE SYSTEM
Type of Device
HAMMERTUBE IMPLANT
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7206431300
MDR Report Key10933201
MDR Text Key219548916
Report Number3008650117-2020-00209
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP40-002-0275-S
Device Catalogue NumberP40-002-0275-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2018
Initial Date FDA Received12/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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