SWANSON FLEXIBLE HINGE TOE WITH GROMMETS G426-0002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for SWANSON FLEXIBLE HINGE TOE WITH GROMMETS G426-0002 manufactured by Wright Medical Technology, Inc..

Event Text Entries

[45756278] The investigation is not complete. When the investigation is complete, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10


[45756279] It was reported that there were inadequate labeling on implant indicating short stem or regular. On the short stem implant there is only a letter "s" next to the size number on the regular stem there is only a size number. This causes confusion to staff. There should be clearer labeling stating short stem or regular. Add'l info rec'd 4/22/2016: loan set ordered was short stem. Company set regular. One the box there is only a letter "s" to distinguish. "in my opinion, it's not good enough. Short or regular should be written. " patient was transferred to theatre recovery until a new implant was sent by courier. Waiting time 2. 5 hours. This implant error was discovered during surgery although implants were checked prior to the case. There is no suitable sizes (ie. Short/regular stem) clearly written.
Patient Sequence No: 1, Text Type: D, B5


[48336948] This incident is considered closed. If at any time new or updated information becomes available, the incident will be re-opened and investigated.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1043534-2016-00032
MDR Report Key5673935
Date Received2016-05-23
Date of Report2016-05-20
Date of Event2016-04-08
Date Mfgr Received2016-06-28
Date Added to Maude2016-05-23
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 Street1023 CHERRY ROAD
Manufacturer CityMEMPHIS TN 38117
Manufacturer CountryUS
Manufacturer Postal38117
Manufacturer Phone901290-566
Manufacturer G1WRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Street11576 MEMPHIS ARLINGTON RD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWANSON FLEXIBLE HINGE TOE WITH GROMMETS
Generic NameSMALL JOINT COMPONENT
Product CodeKWH
Date Received2016-05-23
Catalog NumberG426-0002
Lot Number1550792
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Address11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-05-23

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