MAUDE Adverse Event Report: ARTHREX INC. FOREFOOT INTERNAL BRACE IMPLANT SYSTEM, PEEK; SCREW, FIXATION, BONE

Catalog Number	AR-1530P-CP
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	12/30/2017
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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the screw's thread was slightly damaged (stripped and dented).Additionally, the screw's critical dimensions were within specification.The contribution of the device to the reported event could not be determined.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 after a distal extremities hallux varus toe procedure on (b)(6) 2017, the implant pulled out post-op.The revision surgery was on (b)(6) 2017 to remove the implant and implanted another ar-1530p-cp from the same lot.Currently the patient is fine to date.Follow-up investigation: surgeon confirmed to sales rep that there was no reported patient injury or trauma post op and patient was very compliant.Per surgeon post op follow up visit at surgeon office showed sign of implant failure (anchor pulled out).The ar-1530p-cp was collected and is being returned for evaluation.Patient was a female.

• Brand Name: FOREFOOT INTERNAL BRACE IMPLANT SYSTEM, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7224272
• Report Number: 1220246-2018-00020
• Device Sequence Number: 16719429
• Product Code: HWC
• UDI-Device Identifier: 00888867242081
• UDI-Public: 00888867242081
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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): 01/29/2018

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: 07/01/2022
• Device Catalogue Number: AR-1530P-CP
• Device Lot Number: 10154669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/29/2018
• 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