MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW; INTRAMEDULLARY FIXATION ROD SYSTEM

Model Number	Lag Screw
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
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.The involved implant was not available to the company; thus, its physical examination was not possible.An x-ray of the case was provided to the manufacturer.It should be noted, that the titanium shell is attached to the lag screw during the molding process and thus in order to disconnect the two, high torque forces are required.In the involved case, it is possible that the lag screw was inserted too deep and reached the bone cortex.Thus when it was unscrewed for extraction, high forces were applied on the screw's thread leading to the separation of the titanium shell.
Event or Problem Description
During implantation of a piccolo composite pf nail in (b)(6), after lag screw insertion and x-ray examination, the surgeon decided to remove the lag screw and replace it with a shorter lag screw since it was too long.After lag screw removal, the surgeon discovered that the titanium shell at the lag screw distal end separated from the lag screw and remained in the bone.A shorter lag screw was inserted with shell remaining in situ.

• Brand Name: PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW
• Common Device Name: INTRAMEDULLARY FIXATION ROD SYSTEM
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 11997309
• Report Number: 9615128-2021-00003
• Device Sequence Number: 3560490
• Product Code: HSB
• UDI-Device Identifier: 07290109337852
• UDI-Public: (01)07290109337852(17)240701(10)PPF01726
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: Lag Screw
• Device Catalogue Number: PPFLS10095
• Device Lot Number: PPF01726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1