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

Model Number Lag Screw

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

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 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
• Type of Device: INTRAMEDULLARY FIXATIONB ROD SYSTEM; BONE SCREW
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: hila wachsler-avrahami ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 7662205
• MDR Text Key: 113194658
• Report Number: 9615128-2018-00004
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07290109335476
• UDI-Public: (01)07290109335476(17)230101(10)PPF01268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR