Bone Anchors with Arthroscopic Delivery System 2503-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00854501006173), received between Sep 9, 2019 and Sep 9, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 18, 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.

• InjurySep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER PROCEDURE, WHERE REGENETEN BIOINDUCTIVE IMPLANT WAS USED, THE PATIENT HAD PAIN AND IRRITATION ON (B)(6) 2021. ON A SECOND SURGERY, IT WAS NOTICED THAT THE DEVICE BECOME DISLODGED AND WAS NOT SECURED TO THE SUPRASPINATUS TENDON. IT HAD BUNCHED UP AND WAS PARTIALLY ATTACHED TO THE ACROMION. THE IMPLANT , BONE ANCHORS AND TENDON ANCHORS WERE REMOVED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain; Skin Inflammation/ Irritation

  MAUDE report 12445088 ↗
• MalfunctionAug 3, 2021Break; Difficult to Insert; Connection Problem; Material Twisted/Bent; Positioning Problem; Break; Difficult to Insert; Connection Problem; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT, DURING A REVISION RCR SURGERY, THE TENDON ANCHOR INSERTER WAS NOT LOADING THE ANCHORS FROM THE PUCK CORRECTLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTES SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271210 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER OPERATION, THE PATIENT RETURNED TO THE CLINIC WITH PAIN AND INFLAMMATION. THE MRI REVEALED INFLAMMATION AND THE PRESENCE OF RICE BODIES. THE PATIENT WAS POSITIVE FOR INFECTION AND WAS TREATED WITH ANTIBIOTICS. CURRENTLY, THE PATIENT IS WAITING ON WORKERS COMPENSATION APPROVAL FOR REVISION/SECOND LOOK.

  Patient problems: Foreign Body Reaction; Inflammation; Pain; Unspecified Infection

  MAUDE report 11823512 ↗
• MalfunctionDec 11, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE TENDON ANCHORS WERE BEING INSERTED INTO THE TENDON ANCHOR INSERTER THEY BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10990993 ↗
• MalfunctionAug 24, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY THE TENDON ANCHORS WERE NOT BEING GRASPED BY TENDON INSERTER (BONE ANCHORS 3 W ARTHRO DEL SYSTEM). THE CORRECT TECHNIQUE WAS BEING USED, BUT THE TENDON INSERTER APPEARED TO BE MANGLED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446294 ↗
• MalfunctionAug 24, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY THE TENDON ANCHORS WERE NOT BEING GRASPED BY TENDON INSERTER (BONE ANCHORS 3 W ARTHRO DEL SYSTEM). THE CORRECT TECHNIQUE WAS BEING USED, BUT THE TENDON INSERTER APPEARED TO BE MANGLED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446219 ↗
• MalfunctionDec 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DISTAL PART OF THE INSERTER CAME OFF AFTER DEPLOYING THE PATCH. IT CAME OFF AFTER THE PATCH WAS TACKED DOWN WHILE ATTEMPTING TO REMOVE INSERTER FROM THE PATIENT'S SHOULDER. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES BUT THERE WAS A DELAY GREATER THAN 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9520578 ↗
• MalfunctionOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TENDON STAPLER HAD A FAILURE, OUT OF ALL 4 STAPLERS AND 3 PUCKS ON TENDON ANCHORS, 2 SUCCESSFULLY GRABBED AND 1 SUCCESSFULLY IMPLANTED. A BACK UP DEVICE WAS AVAILABLE AND A DELAY GREATER THAT 30 MINUTES WAS REPORTED. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216647 ↗
• MalfunctionSep 17, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE TENDON ANCHORS WERE UNABLE TO BE LOADED FROM THE CONTAINER ONTO THE STAPLERS. WHEN A STAPLER WAS INTRODUCED TO ONE OF THE HOLES OF THE CONTAINER AND THE STAPLER TRIGGER WAS SQUEEZED, THE INNER PINS OF THE STAPLER WENT AROUND THE TENDON ANCHOR LIKE NORMAL, BUT WAS UNABLE TO GRASP IT. THE INNER PINS SLID OFF THE TENDON ANCHOR WITHOUT REMOVING THE ANCHOR FROM ITS POSITION WITHIN THE CONTAINER. THIS WAS ATTEMPTED ON EACH STAPLE IN THE CONTAINER WITH BOTH STAPLERS, BUT ONLY 3 OF THEM WERE ABLE TO BE LOADED. TO SOLVE THE ISSUE, ADDITIONAL TENDON ANCHORS AND TENDON STAPLERS WERE OPENED. ALL STAPLERS THAT WERE OPENED WERE USED. EVENTUALLY, BETWEEN THE TWO SETS, 6 STAPLES WERE RETRIEVED AND USED. THE SURGERY WAS DELAYED FOR 8-10 MIN. THE PATIENT WAS STATED TO BE HARMED BECAUSE OF THE BLOOD LOSS DUE TO THE EXTENDED SURGICAL TIME; THE SWELLING INCREASED DUE TO ADDITIONAL SALINE HAVING TO BE PUMPED INTO THE SHOULDER, WHICH CAN CAUSE ADDITIONAL PAIN. ADDITIONAL STRETCHING OF MUSCLE SURROUNDING SUBACROMIAL SPACE WAS REQUIRED TO SEE PROPERLY DUE TO SWELLING AND ADDITIONAL TISSUE RESECTION WAS REQUIRED TO SEE PROPERLY DUE TO SWELLING.

  Patient problems: Blood Loss; Inflammation

  MAUDE report 9076592 ↗
• MalfunctionSep 17, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE TENDON ANCHORS WERE UNABLE TO BE LOADED FROM THE CONTAINER ONTO THE STAPLERS. WHEN A STAPLER WAS INTRODUCED TO ONE OF THE HOLES OF THE CONTAINER AND THE STAPLER TRIGGER WAS SQUEEZED, THE INNER PINS OF THE STAPLER WENT AROUND THE TENDON ANCHOR LIKE NORMAL, BUT WAS UNABLE TO GRASP IT. THE INNER PINS SLID OFF THE TENDON ANCHOR WITHOUT REMOVING THE ANCHOR FROM ITS POSITION WITHIN THE CONTAINER. THIS WAS ATTEMPTED ON EACH STAPLE IN THE CONTAINER WITH BOTH STAPLERS, BUT ONLY 3 OF THEM WERE ABLE TO BE LOADED. TO SOLVE THE ISSUE, ADDITIONAL TENDON ANCHORS AND TENDON STAPLERS WERE OPENED. ALL STAPLERS THAT WERE OPENED WERE USED. EVENTUALLY, BETWEEN THE TWO SETS, 6 STAPLES WERE RETRIEVED AND USED. THE SURGERY WAS DELAYED FOR 8-10 MIN. THE PATIENT WAS STATED TO BE HARMED BECAUSE OF THE BLOOD LOSS DUE TO THE EXTENDED SURGICAL TIME; THE SWELLING INCREASED DUE TO ADDITIONAL SALINE HAVING TO BE PUMPED INTO THE SHOULDER, WHICH CAN CAUSE ADDITIONAL PAIN. ADDITIONAL STRETCHING OF MUSCLE SURROUNDING SUBACROMIAL SPACE WAS REQUIRED TO SEE PROPERLY DUE TO SWELLING AND ADDITIONAL TISSUE RESECTION WAS REQUIRED TO SEE PROPERLY DUE TO SWELLING.

  Patient problems: Blood Loss; Inflammation

  MAUDE report 9076584 ↗
• MalfunctionSep 9, 2019Unintended Ejection; Connection Problem; Unintended Ejection; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE TENDON ANCHOR COULD NOT BE INITIALLY LOADING ONTO THE TENDON STAPLER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974318 ↗