MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. CARBOCLEAR PEDICLE SCREW SYSTEM; PEDICLE SCREW REMOVAL TOOL

Model Number	Extractor
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the production records of the involved item indicated it was manufactured according to specification.The involved item was received and underwent an examination.The visual examination (under a microscope) revealed bending fracture at the mid shaft in its slotted area.It is noted, that the use of the device in very hard bone (as in the involved case) may have contributed to the reported fault.Nevertheless, the company has decided to improve the device in order to minimize probability of recurrence.
Event or Problem Description
During a surgery with the carboclear pedicle screw system, for the treatment of oncological patient, a screw removal tool broke while trying to remove the distal part of a broken screw.The surgeon used another tool to retrieve the screw and surgery was successfully completed.

• Brand Name: CARBOCLEAR PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW REMOVAL TOOL
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 10167005
• Report Number: 9615128-2020-00007
• Device Sequence Number: 3636554
• Product Code: NKB
• UDI-Device Identifier: 07290110205744
• UDI-Public: (01)07290110205744(10)73320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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 Model Number: Extractor
• Device Catalogue Number: PPS922950
• Device Lot Number: 73320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR