MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE DISTAL FEMUR PLATE; BONE PLATE

Model Number	Distal Femur Plate
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The case involved a comminuted fracture of the femur in a (b)(6)-year old patient with a knee prothesis.Examination of the involved implant, as well as its production records, indicated it was manufactured according to specification.X-rays provided to the company, revealed nonunion of the fracture.Importantly, the plate supported the fracture for more than 7 months; it finally failed at the area of bone fracture most probably due to a combination of fatigue and excessive bending load.Studies show that complications following treatment with distal femur plates, including nonunion and implant failure, are not infrequent (1).According to hoffmann et al., hardware failure was related to nonunion; additionally, fractures proximal to total knee arthroplasties had a significantly greater rate of failed hardware (2).Their study demonstrated implant failure rates of 9.9% and nonunion rates of 3.6%.Henderson ce et al, locking plates for distal femur fractures: is there a problem with fracture healing? journal of orthopaedic trauma: february 2011 - volume 25 - issue - p s8-s14.Hoffmann mf et al., clinical outcomes of locked plating of distal femoral fractures in a retrospective cohort.J orthop surg res.2013; 8: 43.
Event or Problem Description
A distal femur plate was implanted (in (b)(6)), to treat a periprosthetic comminuted fracture in a (b)(6)-year old patient.Approximately 7.5 months after implantation, the plate broke during a physiotherapy treatment.The plate was removed and replaced.

• Brand Name: PICCOLO COMPOSITE DISTAL FEMUR PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 10383121
• Report Number: 9615128-2020-00010
• Device Sequence Number: 13757697
• Product Code: HRS
• UDI-Device Identifier: 07290109335247
• UDI-Public: (01)07290109335247(17)231101(10)91741
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K143496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2020

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 Expiration Date: 11/01/2023
• Device Model Number: Distal Femur Plate
• Device Catalogue Number: DFERN1810
• Device Lot Number: 91741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/09/2020
• 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: Required Intervention