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

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.

• 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 Key: 5673935
• MDR Text Key: 45756278
• Report Number: 1043534-2016-00032
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K780132
• Number of Events Reported: 1
• 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 Number: G426-0002
• Device Lot Number: 1550792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR