MAUDE Adverse Event Report: PEGA MEDICAL INC. THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM; SLIM ROD Ø2.0MM X 140MM

Model Number	SLM-20-140
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Cancer (3262)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bone cancer contributed to the non-union of the bone.Also, it is important to note that nonunion is prevalent in the forearm due to the difficulty in maintaining full immobility.Arm movement during normal daily activity exposes the humerus and forearm to large bending forces as they act as levers.Therefore, it is often difficult to achieve bone union, especially when the bone defect is large with cancerous bone, as in this case.The nonunion caused fatigue failure of the exposed slim rod due to cyclic cantilever forces at the fracture site.The fact that there is no visible plastic deformation on the implant confirms the fatigue failure.Furthermore, review of the manufacturing files showed that all dimensional inspections and material mechanical properties were within specifications.
Event or Problem Description
A slim rod inserted into the right ulna of a 6-year-old patient broke at the nonunion site.The nail was implanted on (b)(6) 2019.

• Brand Name: THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM
• Common Device Name: SLIM ROD Ø2.0MM X 140MM
• Manufacturer (Section D): PEGA MEDICAL INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• MDR Report Key: 11117832
• Report Number: 3000327445-2021-00001
• Device Sequence Number: 3950465
• Product Code: HSB
• UDI-Device Identifier: 07540194002662
• UDI-Public: (01)07540194002662
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: SLM-20-140
• Device Catalogue Number: SLM-20-140
• Device Lot Number: 160405-007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/05/2021
• 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: Required Intervention
• Patient Age: 6 YR