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

Catalog Number AR-4151DS

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, 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.No device malfunction can be identified.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device was discarded by the facility.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.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.

Event Description

It was reported by patient that she had surgery on (b)(6) 2015 for the following procedures: right austin bunionectomy, second toe arthrodesis, second metatarsophalangeal joint release, and tailor's bunion exostectomy.During the procedure, an arthrex ar-4151ds, implant delivery system, trim-it drill pin, 1.5mm x 100mm was implanted.Patient states that after 14 months, the pin had not degraded, it had migrated and started protruding and cause her a lot of pain.On (b)(6) 2016, patient underwent a second surgery to remove the implant.When pin was removed it was fully intact with no signs of having begun to degrade.

• 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: 6449705
• MDR Text Key: 71402191
• Report Number: 1220246-2017-00102
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10888867032788
• UDI-Public: 10888867032788
• 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: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: AR-4151DS
• Device Lot Number: 1272780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: 67 YR