MAUDE Adverse Event Report: STRYKER CORP. / WRIGHT MEDICAL TECHNOLOGY, INC. PROSTEP BUNIONETTE MIS; SCREW, FIXATION, BONE

Model Number 977TIMPM

Device Problem Product Quality Problem (1506)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 12/14/2021

Event Type  Injury  

Event Description

This is a poorly designed minimally invasive implant used by underqualified podiatrists.There is a loosely fitted intramedullary rod that is blindly screwed to a distal metatarsal osteotomy fragment.The intramedullary rod toggles in the bone resulting in nonunion of the osteotomy, and in my case destruction of the bone shaft.I need a revision and extensive bone grafting.Fda safety report id# (b)(4).

• Brand Name: PROSTEP BUNIONETTE MIS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER CORP. / WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 14194643
• MDR Text Key: 290097682
• Report Number: MW5109312
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 977TIMPM
• Device Lot Number: 1716067
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE 50 MCG; MULTIVITAMIN ; TYLENOL; VITAMIN D 2000 IU
• Patient Outcome(s): Required Intervention; Hospitalization; Other; Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White