MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE FEMORAL/TIBIAL NAILING SYSTEM - DRILL BIT; INTRAMEDULLARY NAILING SYSTEM; DRILL BIT

Model Number	Drill Bit
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The item was received and underwent visual inspection.Examination of the production records of involved device did not reveal deviation from item specification.
Event or Problem Description
During operation, a drill bit broke at the connection area to the drill.

• Brand Name: PICCOLO COMPOSITE FEMORAL/TIBIAL NAILING SYSTEM - DRILL BIT
• Common Device Name: INTRAMEDULLARY NAILING SYSTEM; DRILL BIT
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 7693479
• Report Number: 9615128-2018-00005
• Device Sequence Number: 11095311
• Product Code: HSB
• UDI-Device Identifier: 07290109338699
• UDI-Public: (01)07290109338699(17)211001(10)QTN04340A
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K102369
• 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): 07/17/2018

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: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: Drill Bit
• Device Catalogue Number: PN913220
• Device Lot Number: QTN04340A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1