MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; PROXIMAL ULNA PLATE

Catalog Number	APL-PUP-9HR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An implanted proximal ulna plate broke in the weeks following surgery.This patient has a history of surgical complications.
Additional Manufacturer Narrative
The instructions for use for the distal elbow set (which includes proximal ulna plates) include contraindications advising against use on patients with "insufficient quantity or quality of bone".The complainant described the patient as having previously undergone multiple operations for the same fracture (initially using a competitor's plate) and having "extremely brittle bone", as evidenced by the emergence of other fractures during follow-ups.These statements were further supported by fluoroscopic images showcasing significant bone loss and the presence of a competitor's "home run" screw which had broken off at the head and been left in the bone.This patient may not have been suitable for implantation of this device given the distal elbow set's contraindications for patients with insufficient quantity or quality of bone.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: PROXIMAL ULNA PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 400; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 400; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 400; miami, FL 33156 ; 3055967585
• MDR Report Key: 17408322
• Report Number: 3006742481-2023-00014
• Device Sequence Number: 12243100
• Product Code: HRS
• UDI-Device Identifier: 00841506105826
• UDI-Public: 00841506105826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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 Catalogue Number: APL-PUP-9HR
• Device Lot Number: DJ2002017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/27/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG