JAWS NITINOL STAPLE SYSTEM P71-020-2020-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for JAWS NITINOL STAPLE SYSTEM P71-020-2020-S manufactured by Paragon 28, Inc..

Event Text Entries

[188695146] This is the second of two reports (see 3008650117-2020-00012) in relation to the report of two broken staples. During evaluation and investigation, the implants were not available for analysis. The implants are not expected to be returned for the manufacturer review/investigation. The device history records were reviewed and showed that parts were manufactured and inspected within all critical specifications of the device manufacturing record. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10


[188695147] It was reported that a paragon 28 jaws 20mm staple was implanted for a talonavicular fusion. The staple broke post-operatively at the junction of the staple bridge and leg. The broken staple was revised. The revision date, patient information, and information regarding the patient health after the implant breakage was not reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008650117-2020-00013
MDR Report Key9892160
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-27
Date of Report2020-03-27
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMACKENZIE BELDEN
Manufacturer Street14445 GRASSLANDS DR.
Manufacturer CityENGLEWOOD, CO
Manufacturer CountryUS
Manufacturer Phone6431300
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJAWS NITINOL STAPLE SYSTEM
Generic NameBONE STAPLE
Product CodeJDR
Date Received2020-03-27
Model NumberP71-020-2020-S
Catalog NumberP71-020-2020-S
Lot Number260305118A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPARAGON 28, INC.
Manufacturer Address14445 GRASSLANDS DR. ENGLEWOOD, CO US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-27

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