MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC. SWANSON FLEX HINGE LATERAL TOE INSTRUMENT + IMPLANT; PROSTHESIS, TOE. CONSTRAINED, POLYMERIC

Model Number 62387001

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2018

Event Type  malfunction  

Event Description

During osteotomy of left foot, the tips of two different rasps broke off into the bone.The surgeon was unable to remove and they were left in the foot.

• Brand Name: SWANSON FLEX HINGE LATERAL TOE INSTRUMENT + IMPLANT
• Type of Device: PROSTHESIS, TOE. CONSTRAINED, POLYMERIC
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC.; memphis TN
• MDR Report Key: 7757330
• MDR Text Key: 116451897
• Report Number: MW5078900
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 62387001
• Device Lot Number: 33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR