REELX STT 4.5MM KNOTLESS ANCHOR 3910-600-062

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-18 for REELX STT 4.5MM KNOTLESS ANCHOR 3910-600-062 manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[184433975] Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


[184433976] It was reported that the anchor broke during the procedure. All pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2020-00129
MDR Report Key9850312
Report SourceDISTRIBUTOR
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-13
Date Mfgr Received2020-02-25
Device Manufacturer Date2018-08-11
Date Added to Maude2020-03-18
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 ContactMR. ANDREA ZENERE
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY-SAN JOSE
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal Code95138
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREELX STT 4.5MM KNOTLESS ANCHOR
Generic NameFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Product CodeMBI
Date Received2020-03-18
Returned To Mfg2020-03-10
Catalog Number3910-600-062
Lot Number18223AG2
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY-SAN JOSE
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.