MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURETAK; SCREW, FIXATION, BONE

Model Number SUTURE ANCHOR, PEEK SUTURETAK

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, it was reported by a patient that he underwent an internal brace procedure for a ligament repair in the ankle, in which the surgeon removed the entire ligament.An anchor was implanted in the patient and it loosened post operative.Patient has sought out recommendations from other surgeons, however, the surgeon who performed the original procedure wants to do a revision surgery and implant a bigger anchor and cement it in.Additional information received on 6/3/2022: per patient, he has undergone a revision surgery with a different surgeon than the one who performed original procedure.Additional information received on 6/23/2022: original procedure was an right ankle instability with internal brace, performed on (b)(6) 2020.By (b)(6) of 2021, patient reported being able to walk and exercise.However, in late (b)(6) of 2021, patient started to experience hip pain by (b)(6), could not longer walk.Around late (b)(6) or early (b)(6), patient woke up one day with a very swollen ankle and was unable to walk to three days.Over the course of three weeks, the swollenness went down and during that time, patient had an x-ray performed as well as an mri.The x-ray did not seem to reveal any issues but the mri showed a loose anchor and a possible tear in the ligament material.Patient then, went to see another surgeon, who performed the revision surgery.Patient was by surgeon, post operation, that only one of the anchors were removed but the other one remains, as it was too difficult to remove.Patient believes that during revision surgery, a donors ligament was implanted and had an osteotomy of the heel.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK
• 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 ; 8009337001
• MDR Report Key: 14976772
• MDR Text Key: 295615601
• Report Number: 1220246-2022-05212
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867024168
• UDI-Public: 00888867024168
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/11/2022

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
• Device Operator: Health Professional
• Device Model Number: SUTURE ANCHOR, PEEK SUTURETAK
• Device Catalogue Number: AR-1934PS
• Device Lot Number: 11435022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/11/2022
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other