MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; GEMINUS VOLAR DISTAL PLATE

Model Number GEMINUS Volar Distal Radius Plate, Standard, 4 Hole, Left

Device Problems Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

No device problems were identified.Several attempts were made to get more information, however all attempts were unsuccessful.The instructions for use for the system states: "do not permanently implant the pre-loaded drill guides, drill blocks, or a.I.M.Ing guides; they are intended to be removed prior to peg insertion.".

Event Description

Fda report was received that a small pre-attached drill guide to the plate was inadvertently left in place at the conclusion of wrist surgery.

• Brand Name: SKELETAL DYNAMICS
• Type of Device: GEMINUS VOLAR DISTAL PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• Manufacturer Contact: mehr malek ; 7300 n. kendall drive; suite 400; miami, FL 33156 ; 3055967585
• MDR Report Key: 11453733
• MDR Text Key: 238912869
• Report Number: 3006742481-2021-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841506101590
• UDI-Public: 00841506101590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GEMINUS Volar Distal Radius Plate, Standard, 4 Hole, Left
• Device Catalogue Number: GMN-LTS-4HL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other