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SYNTHES 5 DEGREE BEND Back to Search Results
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.
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Type of Device5 DEGREE BEND
Manufacturer (Section D)
pinellas park FL
MDR Report Key15258995
MDR Text Key298245047
Report Number15258995
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number04.233.930S
Device Catalogue Number04233930S
Device Lot Number292P683
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2022
Distributor Facility Aware Date07/11/2022
Event Location Hospital
Date Report to Manufacturer07/22/2022
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/19/2022 Patient Sequence Number: 1