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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON FLEXIBLE HINGE TOE WITH GROMMETS; SMALL JOINT COMPONENT

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WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON FLEXIBLE HINGE TOE WITH GROMMETS; SMALL JOINT COMPONENT Back to Search Results
Catalog Number G426-0002
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Code Available (3191)
Event Date 04/08/2016
Event Type  Injury  
Manufacturer Narrative
The investigation is not complete.When the investigation is complete, this report will be updated.
 
Event Description
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.
 
Manufacturer Narrative
This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.
 
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Brand Name
SWANSON FLEXIBLE HINGE TOE WITH GROMMETS
Type of Device
SMALL JOINT COMPONENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
1023 cherry road
memphis, TN 38117
901290-566
MDR Report Key5673935
MDR Text Key45756278
Report Number1043534-2016-00032
Device Sequence Number1
Product Code KWH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K780132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberG426-0002
Device Lot Number1550792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/21/2016
Initial Date FDA Received05/23/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
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