MAUDE Adverse Event Report: JOHNSON SCREWS

Model Number 214.840

Device Problems Break (1069); Defective Component (2292); Structural Problem (2506)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378); Inadequate Pain Relief (2388)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Patient underwent right knee arthroscopy with lateral release and tibial tubercle transfer on (b)(6) 2022.She reports that yesterday she was cleaning her incisional area in the bathroom and got up and walked without any brace or crutch.She felt that her knee twisted as she stepped and she fell.She felt immediate increase in pain and a pop over the knee.She presented to the emergency department who obtained x-rays showing evidence of a displaced tibial tubercle fracture.

• Brand Name: SCREWS
• Type of Device: SCREWS
• Manufacturer (Section D): JOHNSON
• MDR Report Key: 15258986
• MDR Text Key: 298245211
• Report Number: 15258986
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2022,07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214.840
• Device Catalogue Number: 214840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2022
• Distributor Facility Aware Date: 07/07/2022
• Event Location: Home
• Date Report to Manufacturer: 07/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 58 KG