MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE TIBIAL NAIL; INTRAMEDULLARY FIXATION ROD

Model Number	Tibial Nail
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Seizures (2063)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The involved nail was implanted in a patient (b)(6).Approximately 10 weeks post-operation, the patient had seizure and fell.Due to the second trauma (fall), the nail broke.Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.It is noted, that during the revision surgery a larger nail was implanted.Although requested, the involved nail was not available to the manufacturer for its examination.
Event or Problem Description
The involved product (11 mm diameter tibial nail) was implanted on (b)(6) 2016 in a patient (b)(6).According to the information provided to the company, patient fell while having a seizure, and nail broke.Nail was removed on (b)(6) 2017, and replaced with a larger nail of another company (of 12 mm diameter).

• Brand Name: PICCOLO COMPOSITE TIBIAL NAIL
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 6833729
• Report Number: 9615128-2017-00001
• Device Sequence Number: 1430641
• Product Code: HSB
• UDI-Device Identifier: 07290109332390
• UDI-Public: (01)07290109332390(17)210401(10)QTN0181915
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

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: Physician
• Device Expiration Date: 04/01/2021
• Device Model Number: Tibial Nail
• Device Catalogue Number: PTN11380
• Device Lot Number: QTN0181915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 08/31/2017
• 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: 36 YR
• Patient Weight: 113