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 Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on information provided to the company, tapping was not performed prior to lag screw insertion into the bone.As indicated in the system ifu and surgical technique, tapping should be performed before lag screw threading into the bone, using the provided bone tap.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.However, the company did receive a photo of the lag screw and the titanium shell.According to the photo, the titanium shell was complete but separated from the lag screw.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.These forces may be produced in the event that tapping is not performed, as in the involved case.According to the incident report, the lag screw was inserted into the bone too deep and then unscrewed.It is unclear how the surgeon could detect foil separation at this stage, since lag screw is in the bone and not exposed.
Event or Problem Description
During implantation of a piccolo composite pf nail in (b)(6), after lag screw insertion, the surgeon wanted to slightly unscrew the lag screw since it was inserted too deep.During unscrewing of the lag screw the titanium shell at the lag screw distal end separated from the lag screw and remained in the bone.The surgery was converted to a total hip replacement.

• 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: 10077993
• Report Number: 9615128-2020-00006
• Device Sequence Number: 14434122
• Product Code: HSB
• UDI-Device Identifier: 07290109335476
• UDI-Public: (01)07290109335476(17)220501(10)PPF01134
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: Lag Screw
• Device Catalogue Number: PPFLS10100
• Device Lot Number: PPF01134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 50