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

Model Number	IMPLATE Nail, Metacarpal, Mini
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient is a 60-year-old right-hand-dominant male.Surgeon reported that the patient was non-compliant and did not follow post-implantation instructions.The patient often played his guitar, mowed his lawn, and prior to the revision surgery got into a physical altercation which resulted in a third metacarpal base fracture.This failure does not appear to be due to a skeletal dynamics device malfunction.The patient was known to be involved in strenuous physical activities during recovery which likely affected the site's potential to fuse and caused the metacarpal screw to back out.
Event or Problem Description
The surgeon noticed the distal screw was backing out of the medullary rod in the 3rd metacarpal during a follow-up visit three months post-implantation.

• Brand Name: IMPLATE
• Common Device Name: WRIST ARTHRODESIS NAIL SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS; 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: 15293376
• Report Number: 3006742481-2022-00007
• Device Sequence Number: 20415709
• Product Code: HSB
• UDI-Device Identifier: 00841506102153
• UDI-Public: 00841506102153
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: IMPLATE Nail, Metacarpal, Mini
• Device Catalogue Number: IMP-MCN-S40
• 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: 07/29/2022
• Initial Report FDA Received Date: 08/25/2022
• 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 Age: 60 YR
• Patient Sex: Male