MAUDE Adverse Event Report: ARTHREX, INC. TRIM-IT DRILL PIN, 1.5MM X 100MM; PIN, FIXATION, SMOOTH

Catalog Number AR-4151DS

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2015

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 device was requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event include not pre-drilling the pilot hole when hard bone is encountered, exposing too much of the pin in the driver during insertion, and/or over-flexing the device during use.Per device directions for use, over-flexing of the device may cause breakage or cracking.This is the first complaint of this type for this part/lot combination.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.

Event Description

It was reported that a 1.5mm trim-it drill pin was selected for use in a procedure.While inserting the absorbable trim-it pin, the guide point broke off of the pin.Follow-up investigation: the surgeon pre-drilled with a metal pin that was utilized before attempting to insert the all bio-absorbable trim-it pin.As the surgeon drilled into the bone, the trim-it pin prematurely snapped off.Approximately 2-3 mm of the bio-pin broke-off in the patient.The broken pin remained in the patient.

• Brand Name: TRIM-IT DRILL PIN, 1.5MM X 100MM
• 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: 5323514
• MDR Text Key: 34269409
• Report Number: 1220246-2015-00378
• 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 Expiration Date: 03/01/2017
• Device Catalogue Number: AR-4151DS
• Device Lot Number: 1254492
• 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
• 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