MAUDE Adverse Event Report: ARTHREX INC. TENODESIS SCREW,BIO-COMPOSITE; SCREW, FIXATION, BONE

Catalog Number AR-1530BC

Device Problems Break (1069); Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/11/2018

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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.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 had previously been reported by a patient the she underwent a hallux rigidus procedure on her right foot on (b)(6) 2017.Patient had been experiencing significant pain in her foot which began after the surgery.On (b)(6) 2018 x-ray confirmed a piece of the inserter device for the ar-1530bc screw that was being implanted had broken off in her foot.Surgeon acknowledged to patient that he was aware at the time of the procedure that the device piece was being left in her foot.The patient had reported that the device piece was protruding up toward the top of her toe which was causing significant pain as it was pushing against the tendon.On (b)(6) 2018 patient reported that she was planning to obtain a second opinion instead of allowing the original surgeon to remove the device piece from her foot.Patient called on (b)(6) 2018 to report that she had revision surgery on (b)(6) 2018, performed by a different surgeon, at a different facility.During the revision the surgeon removed all three of the original ar-1530bc implants and the previously unretrieved fragment from the implant inserter device.To complete the procedure the surgeon used four external fixation screws.Patient reported that the revision surgeon disclosed to her that the original surgeon had not performed the initial repair correctly which led to most of her issues with pain and discomfort and that it was not the cause of the implants or the unretrieved fragment that were the cause of her problems.Patient is a female, date of birth (b)(6).

• Brand Name: TENODESIS SCREW,BIO-COMPOSITE
• Type of Device: SCREW, FIXATION, BONE
• 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: 7577709
• MDR Text Key: 110453862
• Report Number: 1220246-2018-00201
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867018600
• UDI-Public: 00888867018600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051726
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: AR-1530BC
• Device Lot Number: 10162009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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: 49 YR