MAUDE Adverse Event Report: SYNTHES 5 DEGREE BEND

Model Number 04.233.930S

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 07/11/2022

Event Type  Injury  

Event Description

Pt s/p im nail left femur due to mvc, moving from wheelchair to bed and felt a pop in left thigh and then pain.Im nail broke, pt taken back to operating room to replace nail and ensure alignment with femur.

• Brand Name: 5 DEGREE BEND
• Type of Device: 5 DEGREE BEND
• Manufacturer (Section D): SYNTHES; pinellas park FL
• MDR Report Key: 15258995
• MDR Text Key: 298245047
• Report Number: 15258995
• Device Sequence Number: 1
• Product Code: HSB
• 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: 07/22/2022

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 Model Number: 04.233.930S
• Device Catalogue Number: 04233930S
• Device Lot Number: 292P683
• 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: 07/11/2022
• Event Location: Hospital
• 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: 21 YR
• Patient Sex: Female
• Patient Weight: 71 KG