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	Bone Fracture(s) (1870)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.According to the literature, complications related to slow healing, including nonunion and delayed union, and implant failure are not infrequent and are ongoing problems in managing of distal femoral fractures (1, 2).Recent studies found nonunion rates up to 20% (1).In addition, multiple studies have reported locking plate implant failures (2).(1) hoffmann mf et al.Clinical outcomes of locked plating of distal femoral fractures in a retrospective cohort.J orthop surg res 2013, 8:43.Doi: 10.1186/1749-799x-8-43.(2) henderson ch et al.Locking plates for distal femur fractures: is there a problem with fracture healing? j orthop trauma 2011, 25(2)s8-s14.
Event or Problem Description
About 4 weeks after implantation of a piccolo composite distal femur plate, the plate broke and was removed.

• Brand Name: PICCOLO COMPOSITE DISTAL FEMUR PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 6833807
• Report Number: 9615128-2017-00016
• Device Sequence Number: 58749
• Product Code: HRS
• UDI-Device Identifier: 07290109335261
• UDI-Public: (01)07290109335261(17)201201(10)90812
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

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: Physician
• Device Expiration Date: 12/01/2020
• Device Model Number: Distal Femur Plate
• Device Catalogue Number: DFERN1812
• Device Lot Number: 90812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 08/31/2017
• 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: 65 YR