MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE NAILING SYSTEM; PROXIMAL FEMUR LAG SCREW

Catalog Number	PPFLS10090
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Torn Material (3024)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the production records of the involved device did not reveal a deviation from specification that may have contributed to the reported case.Biomechanical tests have been performed to similar products.All tested products successfully passed the biomechanical requirements.It was emphasize to the surgeon, the importance of drilling and tapping in accordance with the lag screw length, as instructed in the ifu "piccolo composite® nailing system - proximal femur instruction for use" 13161_014row - rev 08/17.
Event or Problem Description
During implantation of a piccolo composite proximal femur nail in (b)(6), a lag screw broke.In the time of the screw insertion, the surgeon felt resistance and decided to extract the screw in order to repeat the drilling.During unscrewing, the distal tip of the screw broke and the surgeon extracted the screw leaving the distal end in situ.Another carbofix lag screw was inserted and the surgery was completed successfully.

• Brand Name: PICCOLO COMPOSITE NAILING SYSTEM
• Common Device Name: PROXIMAL FEMUR LAG SCREW
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya 46724 11; IS 4672411
• MDR Report Key: 6910021
• Report Number: 9615128-2017-00046
• Device Sequence Number: 16307474
• Product Code: HSB
• UDI-Device Identifier: 07290109335469
• UDI-Public: 07290109335469
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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: 03/01/2022
• Device Catalogue Number: PPFLS10090
• Device Lot Number: PPF01109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR