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

Model Number	Distal Volar Radius Plate - Narrow
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information and photos provided to the manufacturer, it may be that the breakage of the small fragment near the screw hole is a result of application of excessive force upon screw tightening.This is not expected to adversely affect plate strength, as only a superficial layer was involved.As indicated in the system ifu, the user should avoid the application of high torque during screw tightening.The plate remained in situ with no additional activity required.Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.This report is submitted following an fda inspection at the manufacturer facility.
Event or Problem Description
At the end of implantation of a piccolo composite distal volar radius (dvr) plate (during placement of bone graft), it was noted that a fragment of the plate, at the area of a distal hole, disassociated from the plate.The plate remained intact and only a thin layer was involved.Plate remained in situ.Distal radius was irrigated and closed as usual.

• Brand Name: PICCOLO COMPOSITE DVR PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 6833764
• Report Number: 9615128-2017-00009
• Device Sequence Number: 1522103
• Product Code: HRS
• UDI-Device Identifier: 07290109333878
• UDI-Public: (01)07290109333878(17)201101(10)90782
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K102597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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 Expiration Date: 11/01/2020
• Device Model Number: Distal Volar Radius Plate - Narrow
• Device Catalogue Number: PRRSN2403
• Device Lot Number: 90782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2016
• 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
• Patient Age: 31 YR