MAUDE Adverse Event Report: ARTHREX, INC. TRIM-IT FIXATION SCREW; SCREW, FIXATION, BONE

Catalog Number	AR-4164B
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, 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 if the device may have caused or contributed to the patients experience.An evaluation of the device cannot be performed as only a small piece of the device was returned to arthrex.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Lot number was not provided so device history record review cannot be performed.There is no minimum or maximum established resorption rates for bio-absorbable implants.Bio-absorbable implants are designed with material qualities required to maintain necessary properties throughout the healing process under normal patient conditions.The potential cause(s) of this event will be 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 on (b)(6) 2014, where a trim-it fixation screw, ar-4164b, was implanted into the patient.On (b)(6) 2016, the patient was in surgery to remove the trim-it fixation screw as the head was not being reabsorbed.Parts of the screw were removed and will be sent back for testing.Nothing was put in place of the explanted device.

• Brand Name: TRIM-IT FIXATION SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6240454
• Report Number: 1220246-2016-00601
• Device Sequence Number: 19021683
• Product Code: HWC
• UDI-Device Identifier: 00888867033207
• UDI-Public: 00888867033207
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K041189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/11/2017

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 Catalogue Number: AR-4164B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/11/2017
• 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