NA 10314Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M685103140), received between Sep 22, 2022 and Oct 7, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2022Mechanical Problem; Improper or Incorrect Procedure or Method; Unintended Movement; Mechanical Problem; Improper or Incorrect Procedure or Method; Unintended Movement

  PER OUR RECORDS, THIS VIGILANCE WAS ORIGINALLY SUBMITTED ON 09/15/2017. HOWEVER, UPON REVIEW OF THE MAUDE DATABASE, IT WAS DETERMINED THAT THE REPORT WAS NOT RECEIVED BY THE FDA. THEREFORE, WE ARE RESUBMITTING THIS REPORT IN ITS ENTIRETY AS ORIGINALLY REPORTED TO THE FDA. ORIGINAL SUBMISSION NARRATIVE: PATIENT HAD AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON NOVEMBER 3, 2016 IN WHICH A PARCUS MEDICAL 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHOR WAS IMPLANTED. PATIENT RETURNED TO SURGEON WITH COMPLAINTS OF CONTINUED PAIN AND LIMITED ROM. AN MRI WAS CONDUCTED AND ANCHOR WAS EXPLANTED ON (B)(6) 2017.

  Patient problems: Inadequate Pain Relief; Loss of Range of Motion

  MAUDE report 15561774 ↗
• InjurySep 22, 2022Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Unintended Movement; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Unintended Movement

  PER OUR RECORDS, THIS VIGILANCE WAS ORIGINALLY SUBMITTED ON 15SEP2017. HOWEVER, UPON REVIEW OF THE MAUDE DATABASE, IT WAS DETERMINED THAT THE REPORT WAS NOT RECEIVED BY THE FDA. THEREFORE, WE ARE RESUBMITTING THIS REPORT IN ITS ENTIRETY AS ORIGINALLY REPORTED TO THE FDA. ORIGINAL SUBMISSION NARRATIVE: PATIENT HAD AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON (B)(6) 2017 IN WHICH A PARCUS MEDICAL 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHOR WAS IMPLANTED. PATIENT RETURNED TO SURGEON WITH COMPLAINTS OF CONTINUED PAIN. AN MRI WAS CONDUCTED AND ANCHOR WAS EXPLANTED ON (B)(6) 2017.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15462873 ↗
• InjurySep 22, 2022Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Unintended Movement; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Unintended Movement

  PER OUR RECORDS, THIS VIGILANCE WAS ORIGINALLY SUBMITTED ON 15SEP2017. HOWEVER, UPON REVIEW OF THE MAUDE DATABASE, IT WAS DETERMINED THAT THE REPORT WAS NOT RECEIVED BY THE FDA. THEREFORE, WE ARE RESUBMITTING THIS REPORT IN ITS ENTIRETY AS ORIGINALLY REPORTED TO THE FDA. ORIGINAL SUBMISSION NARRATIVE: PATIENT HAD AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON (B)(6) 2016 IN WHICH A PARCUS MEDICAL 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHOR WAS IMPLANTED. PATIENT RETURNED TO SURGEON WITH COMPLAINTS OF CONTINUED PAIN AND CREPITUS. A SECOND ARTHROSCOPY WAS CONDUCTED AND ANCHOR WAS EXPLANTED ON (B)(6) 2017.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15462643 ↗