MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100; PIN, FIXATION, SMOOTH

Catalog Number AR-4152DS

Device Problems Break (1069); Human-Device Interface Problem (2949)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2015

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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The most likely cause of the guide point breaking away from the absorbable pin is as described in the event that the patient was awake for the procedure and as the surgeon went to insert the trim-it pin, the patient sharply moved her foot causing the surgeon to prematurely break the metal guide tip pin connected to the bio-absorbable portion of the pin.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device expected but not yet returned.

Event Description

It was reported by the facility that the 2mm trim-it drill pin was selected for use in a procedure.While inserting the pin, it was reported that the patient's leg moved and the guide point broke away from the absorbable pin.Follow-up investigation: the surgeon used proper technique during the procedure.The patient was awake for the procedure and as the surgeon went to insert the trim it pin the patient sharply moved her foot causing the surgeon to prematurely break the metal guide tip pin connected to the bio-absorbable portion of the pin.The metal tip is located in the patient's first metatarsal and was not retrieved.

• Brand Name: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Type of Device: PIN, FIXATION, SMOOTH
• 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, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5324721
• MDR Text Key: 34287711
• Report Number: 1220246-2015-00377
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/10/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-4152DS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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