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

Catalog Number	AR-4151DS
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6449705
• Report Number: 1220246-2017-00102
• Device Sequence Number: 16299091
• Product Code: HTY
• UDI-Device Identifier: 10888867032788
• UDI-Public: 10888867032788
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: AR-4151DS
• Device Lot Number: 1272780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR