SCISSORS MCEN145S WORMALD THIN BONE STRA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-26 for SCISSORS MCEN145S WORMALD THIN BONE STRA manufactured by Medtronic Xomed Instrumentation S.a.s.

Event Text Entries

[3588471] It was reported that the hinge on the device (scissors mcen145s wormald thin bone stra) is broken. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5


[11017903] (b)(4). The device (scissors mcen145s wormald thin bone stra) was returned for evaluation. Analysis indicated that the internal wire is broken near the axis of the blade. The impact on the blade shows that the user tried to cut something very hard with excessive force. Note: this mdr is being filed as a result of an internal review of complaints from medtronic? S mxi facility in (b)(4). This review was conducted to resolve several issues discovered in the mxi complaint handling process. Issues resolved include the misclassification of devices returned for repair, as well as gaps in reporting. Mxi capa (b)(4) was opened to address these issues.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680837-2013-00047
MDR Report Key3306983
Report Source01,07
Date Received2013-08-26
Date of Report2009-07-29
Date of Event2009-07-29
Date Mfgr Received2009-07-29
Device Manufacturer Date2006-06-01
Date Added to Maude2013-11-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSHARANYA JANGITI
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328183
Manufacturer G1MEDTRONIC XOMED, INC.
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCISSORS MCEN145S WORMALD THIN BONE STRA
Generic NameSCISSORS, NASAL
Product CodeKBD
Date Received2013-08-26
Returned To Mfg2009-08-04
Model NumberMCEN145S
Catalog NumberMCEN145S
Lot Number06/06
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INSTRUMENTATION S.A.S
Manufacturer AddressLE PAVILLON SAINT-AUBIN-LE-MONIAL 03160 FR 03160


Patients

Patient NumberTreatmentOutcomeDate
10 2013-08-26

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