MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; DISTAL HUMERUS PLATING SYSTEM

Catalog Number	DHPF-MDR-5HL
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the humeral fixation set (which includes distal humerus plates) states the following: "prior to using the humeral fixation set, ensure that none of the following patient conditions are present: active or latent infection, sepsis, osteoporosis, insufficient quantity or quality of bone and/or soft tissue, material sensitivity (if sensitivity is suspected, tests are performed prior to implantation), or patients who are unwilling or incapable of following post operative care instructions." "potential construct failures such as stress fractures of the bones, loosening of the construct and/or fixation, instability, delayed soft tissue healing, soft tissue irritation, delayed fusion, non-fusion, or incomplete healing may occur as a result of noncompliance to post-operative rehabilitation, excessive activities, or construct overloading." "for safe effective use of the implant, the surgeon must be thoroughly familiar with the surgical technique for the device, implant, and associated instruments.Potential failures of the devices in the set 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." "all screws must be implanted and fully tightened to maintain the integrity and strength of the finished construct and the positioning established intraoperatively.If the screws are not attached and/or fully tightened, a non-union, delayed union, soft tissue complication, or construct failure may occur." the surgeon likely did not adequately fixate the plates to the bone, using an insufficient number of screws with a large gap between those which were used.For optimal fixation, all screw holes should be used.Patient conditions may have contributed to this failure.
Event or Problem Description
An implanted distal humerus plate construct disassociated from bone after one month.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: DISTAL HUMERUS PLATING SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer (Section G): 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 ; 3055967585
• MDR Report Key: 20739417
• Report Number: 3006742481-2024-00014
• Device Sequence Number: 8297928
• Product Code: HRS
• UDI-Device Identifier: 00841506129174
• UDI-Public: 00841506129174
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K200367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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
• Device Catalogue Number: DHPF-MDR-5HL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/20/2024
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White