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

Model Number	Lag Screw
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported to the company that tapping was not performed prior to lag screw insertion into the bone.As described in the system ifu and surgical technique, tapping should be performed before lag screw insertion into the bone, using the provided bone tap.It is noted that the operation was satisfactorily completed.Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.
Event or Problem Description
A piccolo composite pf lag screw was damaged during implantation.Another screw was used and the operation was satisfactorily completed.

• Brand Name: PICCOLO COMPOSITE PF NAILING SYSTENM - LAG SCREW
• Common Device Name: INTRAMEDULLARY FIXATIONB ROD SYSTEM; BONE SCREW
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 7662205
• Report Number: 9615128-2018-00004
• Device Sequence Number: 1979545
• Product Code: HSB
• UDI-Device Identifier: 07290109335476
• UDI-Public: (01)07290109335476(17)230101(10)PPF01268
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

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: 01/01/2023
• Device Model Number: Lag Screw
• Device Catalogue Number: PPFLS10100
• Device Lot Number: PPF01268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2018
• Initial Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR