MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE DISTAL FEMUR PLATE - REDUCTION DEVICE (LONG); BONE PLATE SYSTEM

Model Number	Reduction Device - Long
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
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.Breakage of such reduction device ("whirly bird") may occur during operation if excessive lateral force is applied.Device was not available for the manufacturer.
Event or Problem Description
During implantation of a piccolo composite distal femur plate, a reduction device (surgical instrument) broke.The physician removed the broken tip from the bone.

• Brand Name: PICCOLO COMPOSITE DISTAL FEMUR PLATE - REDUCTION DEVICE (LONG)
• Common Device Name: BONE PLATE SYSTEM
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 6864061
• Report Number: 9615128-2017-00043
• Device Sequence Number: 10790187
• Product Code: HRS
• UDI-Device Identifier: 07290109337791
• UDI-Public: (01)07290109337791
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: Physician
• Device Model Number: Reduction Device - Long
• Device Catalogue Number: DF930410
• Device Lot Number: PLN69701A OR PLN01562B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR