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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES 5 DEGREE BEND

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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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Brand Name5 DEGREE BEND
Type of Device5 DEGREE BEND
Manufacturer (Section D)
SYNTHES
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
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