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

Model Number Distal Volar Radius Plate - Narrow

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

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 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
• Type of Device: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: hila wachsler-avrahami ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411 ; 9 9511511
• MDR Report Key: 6833764
• MDR Text Key: 84100964
• Report Number: 9615128-2017-00009
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07290109333878
• UDI-Public: (01)07290109333878(17)201101(10)90782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR