MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; WRIST ARTHRODESIS NAIL SYSTEM

Model Number	IMPLATE Nail, Metacarpal, Standard, 4.6mm
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial implant remains implanted and is not available for return.However, the initial locking screw was discarded during the revision and replaced.Based on the limited information provided, no conclusions can be determined at this time.No trend has been identified at the time of this submission.The patient is still undergoing treatment and status will continue to be monitored.
Event or Problem Description
The metacarpal locking screw backed out of a implant.Revision was performed to stabilize the construct.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: WRIST ARTHRODESIS NAIL SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33156 ; 3055967585
• MDR Report Key: 16322947
• Report Number: 3006742481-2023-00004
• Device Sequence Number: 8023673
• Product Code: HSB
• UDI-Device Identifier: 00841506102177
• UDI-Public: 00841506102177
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Patient Monitoring,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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 Model Number: IMPLATE Nail, Metacarpal, Standard, 4.6mm
• Device Catalogue Number: IMP-MCN-S46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female