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

Catalog Number AR-4151DS

Device Problems Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2017

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, 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.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 the patient underwent a hammertoe repair procedure on her right fourth toe on (b)(6) 2017, using trim it pins.The pin did not perform as it should, and she had to do a second surgery on (b)(6) 2017 to remove the pin.No further details provided at time of initial report.Follow-up investigation from medical records: op report (b)(6) 2017 procedure: the patient implant was an ar-4151ds, implant delivery system, trim-it drill pin 1.5x 100 mm.Patient diagnosis which led to the (b)(6) 2017 procedure was right fourth digit hammertoe.Patient (b)(6) at time of revision.(b)(6) lbs.Height (b)(6) inches, (b)(6).Op report (b)(6) 2017 procedure: on (b)(6) 2017 patient underwent a revision surgery due to painful retained internal fixative, deep right 4th digit.Extensive dissection was needed to remove the trim-it pin.It was necessary to cut the trim-it pin at the level of the distal interphalangeal joint and then it was removed proximally and distally.The proximal portion was found to be in an odd shape and one portion was found to be in a u shape.The second small fragment was removed distally and the entire piece measured 3 cm which was felt to be the entire length of the trim-it pin.Surgeon office records dated (b)(6) 2017: patient reported non-compliance at follow up visit four days post op (b)(6) 2017 procedure.Patient reported walking without her prescribed shoe at night to the bathroom.

• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7105364
• MDR Text Key: 94479744
• Report Number: 1220246-2017-00451
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: AR-4151DS
• Device Lot Number: 10069208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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: 61 YR
• Patient Weight: 63