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

Model Number IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100

Device Problem Device Fell (4014)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during a hammertoe case, while drilling to place the trim it drill pin, the metal drill tip fell off into the toe.It was not removed.

• 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 ; 8009337001
• MDR Report Key: 8008790
• MDR Text Key: 125112359
• Report Number: 1220246-2018-00719
• 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: Other
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Device Catalogue Number: AR-4152DS
• Device Lot Number: 10139619
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2018
• 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