REELX 3910-600-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613252017578), received between Jun 26, 2018 and Feb 9, 2023 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2023Break; Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE AND WAS POTENTIALLY UNABLE TO THE RETRIEVED FROM PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342553 ↗
• MalfunctionJun 22, 2021Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040474 ↗
• MalfunctionApr 13, 2021Break; Break

  WE RECENTLY RECEIVED A PKG. REELX STT 5.5MM KNOTLESS SUTURE ANCHOR AS A COMPLAINT. THE REPORTED COMPLAINT STATES: DURING PROCEDURE, THE TIP OF THE ANCHOR GAVE WAY. THERE WAS NO DELAY FOR THE PATIENT AND NO ADDITIONAL INTERVENTION. THE TIP OF THE ANCHOR BROKE BUT THE FRAGMENTS WERE NOT RECOVERED. THE PROCEDURE WAS COMPLETED WITHOUT A HITCH AFTER CHANGING THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655781 ↗
• MalfunctionMar 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WE RECENTLY RECEIVED THREE (3) PKG. REELX STT 5.5MM KNOTLESS SUTURE ANCHOR AS COMPLAINTS. THE REPORTED COMPLAINT STATES: THE ANCHORS SLIPPED OUT DESPITE PROFESSIONAL IMPLANTATION IN THE HUMERAL HEAD. THE THREE ANCHORS HAD PULLED OUT. DAMAGE WAS NOTED ON THE ANCHORS. THE PATIENT WILL NEED A REVISION SURGERY. DATE OF THE REVISION IS UNKNOWN. HEALING TIME SIGNIFICANTLY PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585731 ↗
• MalfunctionMar 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WE RECENTLY RECEIVED THREE (3) PKG. REELX STT 5.5MM KNOTLESS SUTURE ANCHOR AS COMPLAINTS. THE REPORTED COMPLAINT STATES: THE ANCHORS SLIPPED OUT DESPITE PROFESSIONAL IMPLANTATION IN THE HUMERAL HEAD. THE THREE ANCHORS HAD PULLED OUT. DAMAGE WAS NOTED ON THE ANCHORS. THE PATIENT WILL NEED A REVISION SURGERY. DATE OF THE REVISION IS UNKNOWN. HEALING TIME SIGNIFICANTLY PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585493 ↗
• MalfunctionMar 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WE RECENTLY RECEIVED THREE (3) PKG. REELX STT 5.5MM KNOTLESS SUTURE ANCHOR AS COMPLAINTS. THE REPORTED COMPLAINT STATES: THE ANCHORS SLIPPED OUT DESPITE PROFESSIONAL IMPLANTATION IN THE HUMERAL HEAD. THE THREE ANCHORS HAD PULLED OUT. DAMAGE WAS NOTED ON THE ANCHORS. THE PATIENT WILL NEED A REVISION SURGERY. DATE OF THE REVISION IS UNKNOWN. HEALING TIME SIGNIFICANTLY PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585431 ↗
• InjuryMar 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499055 ↗
• InjuryMar 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499054 ↗
• InjuryMar 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11498045 ↗
• InjuryFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE ANCHOR BROKE DURING THE PROCEDURE AND PIECES REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318204 ↗
• MalfunctionJun 26, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE PRODUCT BROKE. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7639930 ↗