MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; GEMINUS DISTAL RADIUS PLATING SYSTEM

Catalog Number	GMN-LTS-4HL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the geminus distal radius plating system states the following: "all screws must be implanted and fully tightened into the plate to maintain the integrity and strength of the finished construct.If the screws are not attached and/or fully tightened, a non-union, delayed union or construct failure may occur." review of fluoroscopic images from the case revealed that the surgeon did not insert the 3.5mm cortical locking screw, leaving its intended screw hole empty.Discussion with the surgeon further established that they were not following standard practice while preparing the implant site.Under these conditions, the plate failed after five months.
Event or Problem Description
An implanted geminus distal radius plate broke 5 months after surgery.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: GEMINUS DISTAL RADIUS PLATING SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 18443035
• Report Number: 3006742481-2023-00020
• Device Sequence Number: 17846969
• Product Code: HRS
• UDI-Device Identifier: 00841506101590
• UDI-Public: 00841506101590
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K182492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

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 Catalogue Number: GMN-LTS-4HL
• Device Lot Number: DM2303143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White