MAUDE Adverse Event Report: Skeletal Dynamics Inc. Skeletal Dynamics; K-Wire, 1.6mm x 127mm

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Skeletal Dynamics
• Common Device Name: K-Wire, 1.6mm x 127mm
• Manufacturer (Section D): 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 ; +1(305)596-7585
• MDR Report Key: 50462218
• Report Number: 3006742481-2026-00016
• Device Sequence Number: 16001840
• Product Code: LRN
• UDI-Device Identifier: 00841506102504
• UDI-Public: 00841506102504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/25/2026

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 170 LB
• Patient Race: White