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

Catalog Number	AR-4152DS
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional 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.This is one of two submissions from the same case.The other is (b)(4).Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device remained in the patient therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.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 or Problem Description
It was reported that the patient underwent surgery where 3 trim-it pins were implanted into her foot.Since the original surgery, 2 of the 3 pins have been removed.Internal medicine doctor has become involved as the surgery has not helped in relieving the original issue.The dates of the original surgery and revision surgery is not known.

• Brand Name: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6829568
• Report Number: 1220246-2017-00313
• Device Sequence Number: 19190026
• Product Code: HTY
• UDI-Device Identifier: 00888867032811
• UDI-Public: 00888867032811
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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: 09/01/2017
• Device Catalogue Number: AR-4152DS
• Device Lot Number: 700356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/30/2017
• 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