MICROMITE STITCHPAK SUTURE ANCHOR 10301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2007-08-31 for MICROMITE STITCHPAK SUTURE ANCHOR 10301 manufactured by Conmed Linvatec.

Event Text Entries

[703031] It was reported that during hand surgery, this anchor did not deploy which resulted in use of an alternate brand of product to complete the procedure. There was no reported injury and a minimal delay to secure the alternate device during this event.
Patient Sequence No: 1, Text Type: D, B5


[7859954] Investigation findings: this product was returned for evaluation and during testing, the anchor fit into the insertion gun and deployed properly. The reported problem was unable to be duplicated.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1017294-2007-00664
MDR Report Key906181
Report Source00,05,06,07
Date Received2007-08-31
Date of Report2007-08-06
Date of Event2007-08-02
Date Mfgr Received2007-08-06
Date Added to Maude2007-10-10
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 FDA0
Event Location0
Manufacturer ContactBEVERLY SCHANER
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995169
Manufacturer G1CONMED LINVATEC
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal Code33773
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROMITE STITCHPAK SUTURE ANCHOR
Generic NameMICROMITE STITCHPAK
Product CodeNOV
Date Received2007-08-31
Returned To Mfg2007-08-17
Model NumberNA
Catalog Number10301
Lot Number01507
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key887537
ManufacturerCONMED LINVATEC
Manufacturer AddressLARGO FL US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-08-31

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