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

Model Number Tibial Nail

Device Problem Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Seizures (2063)

Event Date 02/08/2017

Event Type  Injury  

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 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
• Type of Device: INTRAMEDULLARY FIXATION ROD
• 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 ; 9 9511511
• MDR Report Key: 6833729
• MDR Text Key: 84093837
• Report Number: 9615128-2017-00001
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07290109332390
• UDI-Public: (01)07290109332390(17)210401(10)QTN0181915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 113