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

Model Number	Proximal Ulna Plate, 73mm, Left
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint part is not expected to be returned for review/investigation.Device part number was given, and a thorough review of device records was conducted and concluded to be within specifications.Several attempts were made to get more information but was unsuccessful.Based on the limited information available, it has been determined that no corrective and/or preventative action is required.This complaint will be accounted for and monitored.
Event or Problem Description
It was reported that a patient underwent an hps fracture surgery and had a triceps avulsion post procedure.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: PROXIMAL ULNA PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• MDR Report Key: 12291240
• Report Number: 3006742481-2021-00007
• Device Sequence Number: 3806805
• Product Code: HRS
• UDI-Device Identifier: 00841506105789
• UDI-Public: 00841506105789
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171590
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: Proximal Ulna Plate, 73mm, Left
• Device Catalogue Number: APL-PUP-3HL
• Device Lot Number: DJ2009036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR