MAUDE Adverse Event Report: ARTHREX INC. STANDARD PROCEDURE PACK; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number ST6100

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.At this time an evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The cause of the event is undetermined.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that during a fibular fracture procedure, the tip of the long gold spade tip guidewire that is part of the procedure pack (st6100), broke-off upon insertion into the fibula.The surgeon was able to make another proximal incision and successfully removed the guidewire fragment.The case was completed with a second standard procedure pack.Follow-up investigation: the long gold spade tip guidewire is a component of the standard procedure pack and the component number is 003-1166.This was a right fibula fracture procedure.Patient, female in her 20's.

• Brand Name: STANDARD PROCEDURE PACK
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7008885
• MDR Text Key: 91307764
• Report Number: 1220246-2017-00427
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: ST6100
• Device Lot Number: CU24041701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 20 YR