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

Model Number	Proximal Ulna Plate, 108mm, Right
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Patient Problem/Medical Problem (2688)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system instructions for use warnings state: for safe effective use of the implant, the surgeon must be thoroughly familiar with the surgical technique for the device, implant, and associated instruments.The triceps was not sutured to the proximal ulna plate as suggested by the surgical technique guide, therefore, concluding that the surgical technique guide was not followed.Potential failures of the system may include delayed union, non-union, loosening of fixation, migration or failure of the device, stress fractures of the bones, or incomplete healing as a result of excessive activity, overloading or noncompliance to post-operative rehabilitation.
Event or Problem Description
Loss of fixation on the olecranon fracture.Medical intervention needed 1 week post-operation.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: PROXIMAL ULNA PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; miami, fl
• MDR Report Key: 10292395
• Report Number: 3006742481-2020-00004
• Device Sequence Number: 3209522
• Product Code: HRS
• UDI-Device Identifier: 00841506105802
• UDI-Public: 00841506105802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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, 108mm, Right
• Device Catalogue Number: APL-PUP-6HR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 07/17/2020
• 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: 80 YR