MAUDE Adverse Event Report: FLOWER ORTHOPEDICS VARIABLE ANGLE LOCKING PEG, D: 1.8MM X L: 20.0MM

Model Number FDR 120

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Device Issue (2379)

Patient Problem No Information (3190)

Event Date 04/27/2017

Event Type  malfunction  

Event Description

Locking peg (fdr 120, lot 1611320064) went through distal radius plate (fdr 011, lot 2014003534).

• Brand Name: VARIABLE ANGLE LOCKING PEG, D: 1.8MM X L: 20.0MM
• Type of Device: LOCKING PEG
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd; suite 280; horsham PA 19044
• Manufacturer (Section G): OMNI COMPONENTS; 46 river dr; hudson NH 03051
• Manufacturer Contact: jessica huang ; 100 witmer rd; suite 280; horsham, PA 19044 ; 2153948903
• MDR Report Key: 6552956
• MDR Text Key: 74871621
• Report Number: 3009996260-2017-00004
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00840118110884
• UDI-Public: 840118110884
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2023
• Device Model Number: FDR 120
• Device Lot Number: 1611320064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR