TruShot Y18TNRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854648985), received between Oct 9, 2023 and Dec 4, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, Y18TN 1.8MM, ALL-SUTR ANCH W/2-#2 (5METRIC) HI-FI SUTURES W/NEEDLES WAS BEING USED ON (B)(6) 2025 AND "AFTER PLACEMENT OF HOOK PLATE AND SCREWS, TRUSHOT ANCHORS WERE USED TO HOLD BIOBRACE (AS AUGMENTATION) ON THE CAPSULAR PART DURING ACJ STABILIZATION. UPON COMPLETION OF ALL STEPS, FINAL X-RAY WAS TAKEN. PART OF THE FORK TIP THAT HOLDS THE ALL-SUTURE ANCHOR FROM TRUSHOT WAS FOUND IN PATIENT¿S BODY. TO PREVENT FURTHER DAMAGE TO SOFT TISSUE AND RISK OF HOOK PLATE DISPLACEMENT, METAL TIP WAS LEFT INSIDE PATIENT¿S BODY. (TRUSHOT WITH Y-KNOT 1.8MM PIN WAS BROKEN INTRAOP). THE BROKEN PIECE WAS LEFT INSITU PATIENT'S RIGHT SHOULDER UNDER ACROMION." THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FOREIGN BODY LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23719843 ↗
• InjuryMar 3, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE Y18TN, 1.8MM,ALL-SUTR ANCH W/2-#2 (5METRIC) HI-FI SUTURE W/NEEDLES, WAS BEING USED ON (B)(6) 2025 DURING A LEFT SHOULDER ARTHROSCOPY PROCEDURE WHEN IT WAS REPORTED ¿FIRST DEVICE FAILED, SECOND DEVICE FAILED, NOT SURE WHICH DEVICE TIP BROKE INTO BONE, SEE MD OPERATIVE NOTE, X- RAY COMPLETED, MD NOT GOING BACK INTO RETRIEVE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE FIRST ANCHOR DEPLOYED DID NOT HOLD AND THE SECOND ANCHOR WAS DEPLOYED AND ALSO DID NOT HOLD AND THE SMALL METAL FORK ON THE DEPLOYING MECHANISM MALFUNCTIONED AND BROKE OFF IN THE MEDULLARY CANAL OF THE HUMERUS. THE PIECE OF METAL IS VERY SMALL AND WITHIN THE MEDULLARY CANAL AND ANY ATTEMPT TO TRY AND RETRIEVE IT WOULD MOST DEFINITELY RESULT IN MORE DAMAGE THAN BENEFIT. NO EXCESSIVE FORCE WAS USED. NO ADDITIONAL COMPLICATIONS TO MY KNOWLEDGE. WE DID OBTAIN FLUOROSCOPIC IMAGES TO ENSURE THAT THE SMALL PIECE OF METAL WAS INDEED IN THE MEDULLARY CANAL OF THE HUMERUS WHERE IT WOULD NOT CAUSE PROBLEMS.". THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN B

  Patient problems: Foreign Body In Patient

  MAUDE report 21503034 ↗
• InjuryMay 8, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, Y18TN, TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR, WAS BEING USED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿I HAVE A TRUSHOT THAT FAILED/PULLED OUT-BROKEN TIP. BICEPS TENODESIS ". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT "ONE OF THE FORKS OF THE DEPLOYMENT TIP BROKE OFF, THE TIP WAS NOT FOUND OR RECOVERED. THE PATIENT WAS NOT HARMED." THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF TIP NOT RECOVERED OR FOUND.

  Patient problems: Foreign Body In Patient

  MAUDE report 19266978 ↗
• InjuryOct 9, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE Y18TN, TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR WAS BEING USED ON APPROXIMATELY (B)(6) 2023 AND THE "TINE BROKE OFF TRUE SHOT. COULD NOT FIND THE TIME OUTSIDE CAPSULE OF KNEE." PER FURTHER ASSESSMENT, "WE TRIED TO RETRIEVE FROM FATTY TISSUE UNDER X-RAY FOR 1 HR COULD NOT FIND IT. 1/2 THE FORK BROKE OFF THE TIP ON IMPACTION." THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FRAGMENTATION, ALTHOUGH NOT FOUND IN THE PATIENT, THEY CANNOT PRODUCE THE PIECE AND ITS LOCATION IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17895722 ↗