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

Catalog Number 5PTN10400

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2017

Event Type  malfunction  

Manufacturer Narrative

The ruler was not received for evaluation.Another radiographic ruler from different lot was tested.The scale and the length of the ruler was measured and found to be correct.In addition, the involved tibial nail was received and underwent an examination as following: the production records of the nail did not reveal deviation from specification.The nail had external marks of extraction.The thread in the distal part of the nail was stripped, however the inner part of the thread was still intact.It seems that excessive force was applied on the nail during its insertion and extraction from the bone.The ruler measurement technique was emphasize again to the surgeon as written in the surgical technique.It was also emphasize to the surgeon, the importance of screwing the removal adaptor all the way in during nail removal.

Event Description

The physician could not get a clear measurement from a ruler.The nail was inserted which ended up being too long.Upon extraction, the threads were stripped using the removal adaptor.After extracting the nail, a carbofix correct size nail was implanted.

• Brand Name: PICCOLO COMPOSITE TIBIAL NAIL
• Type of Device: INTRAMEDULLARY FIXATION ROD SYSTEM
• 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: anna komy ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 6957302
• MDR Text Key: 90433821
• Report Number: 9615128-2017-00047
• Device Sequence Number: 1
• Product Code: HSB
• 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: Other
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 5PTN10400
• Device Lot Number: QTN04527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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