Arthrex® AR-1923BC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867023024), received between Aug 7, 2020 and Sep 30, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fracture

  Patient problems: Pain

  MAUDE report 50948152 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE ANCHOR BROKE IN MANY SMALL PIECES DURING INSERTION. THE BIGGER PARTS WERE RETRIEVED FROM THE PATIENT BUT THE SMALL FRAGMENTS COULD NOT BE FOUND AND REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER COMPANY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23476330 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE ANCHOR BROKE IN MANY SMALL PIECES DURING INSERTION. THE BIGGER PARTS WERE RETRIEVED FROM THE PATIENT BUT THE SMALL FRAGMENTS COULD NOT BE FOUND AND REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER COMPANY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23476127 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE ANCHOR BROKE IN MANY SMALL PIECES DURING INSERTION. THE BIGGER PARTS WERE RETRIEVED FROM THE PATIENT BUT THE SMALL FRAGMENTS COULD NOT BE FOUND AND REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER COMPANY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23476022 ↗
• MalfunctionSep 15, 2025Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WITH LABRUM FIXATION SURGERY 1X AR-1923BC-1 BECAME WEDGED DURING INSERTION. THE ANCHOR WAS ONLY IMPLANTED 40% AND AFTER REMOVAL, THE PUSHLOCK DOWEL WAS TAKEN OUT. A NEW DEVICE WAS OPENED AND THERE WERE NO PROBLEMS. THE OPERATION CONTINUED WITHOUT DELAY AND NO DAMAGE WAS CAUSED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051556 ↗
• MalfunctionJun 23, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A LABRAL REPAIR SURGERY WHEN REMOVING THE IMPLANT FROM THE PACKAGING, THE TIP OF THE ANCHOR DID NOT HOLD AND THE ANCHOR COULD NOT BE INSERTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 09-JUN-2025 ACCORDING TO THE INFORMATION FROM THE HOSPITAL, THE SURGEON TRIED TO INSERT THE ANCHOR, BUT IT WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310628 ↗
• MalfunctionMay 21, 2025Break; Break

  ON 2ND MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1923BC-1, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 2.9 X 15.5 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. ON 5TH MAY 2025 - THE ARTHREX EMPLOYEE REPLIED THAT THIS WAS DETECTED DURING USE IN A STABILISATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE ANCHOR STILL WENT IN, BUT TOP THREADS BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 22059567 ↗
• MalfunctionMay 16, 2025Break; Break

  ON 30TH APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-1923BC-1, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 2.9 X 15.5 MM, THE ANCHORS BROKE DURING INSERTION PROCESS. SOCKETS HAD BEEN DRILLED AND ANCHOR MALLETED DOWN TO BONE, THEN ANCHORS BROKE INTO SEVERAL PIECES WHILE FINAL MALLETING OF ANCHOR INTO SOCKET. THIS WAS DETECTED DURING USE IN A POSTERIOR SHOULDER LABRAL REPAIR FOR INSTABILITY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY CHANGED TO USING PEEK PUSHLOCK ANCHORS INSTEAD OF BIOCOMPOSITE AND ENSURED THAT DRILL HOLES WERE TO CORRECT DEPTH.

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

  MAUDE report 22037510 ↗
• MalfunctionMay 16, 2025Break; Break

  ON 30TH APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-1923BC-1, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 2.9 X 15.5 MM, THE ANCHORS BROKE DURING INSERTION PROCESS. SOCKETS HAD BEEN DRILLED AND ANCHOR MALLETED DOWN TO BONE, THEN ANCHORS BROKE INTO SEVERAL PIECES WHILE FINAL MALLETING OF ANCHOR INTO SOCKET. THIS WAS DETECTED DURING USE IN A POSTERIOR SHOULDER LABRAL REPAIR FOR INSTABILITY PROCEDURE ON 29TH APRIL 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY CHANGED TO USING PEEK PUSHLOCK ANCHORS INSTEAD OF BIOCOMPOSITE AND ENSURED THAT DRILL HOLES WERE TO CORRECT DEPTH.

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

  MAUDE report 22037259 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ELBOW FIXATION SURGERY THE ANCHOR OF THE DEVICE BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125143 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE EYELET OF THE DEVICE BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018769 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT SLIPPED OFF THE BONE . IT WAS FURTHER REPORTED THAT THE DEDICATED DRILL WAS USED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19232887 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A STABILIZATION SURGERY THE ANCHOR BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388548 ↗
• MalfunctionNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ANCHOR DID NOT HOLD AND WAS PULLED OUT DURING A ROTATOR CUFF SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048551 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE SUTURE ANCHOR BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT, OPERATOR, OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564730 ↗
• MalfunctionDec 27, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SUTURE ANCHORS BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050890 ↗
• MalfunctionNov 16, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER BANKART SURGERY, TWO ANCHORS BROKE WHILE THEY WERE INSERTED. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PARTS OUT OF THE PATIENT. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819016 ↗
• MalfunctionNov 8, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY WHEN IMPLANTING THE DEVICE IT BROKE. ALL BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770556 ↗
• MalfunctionNov 8, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY WHEN IMPLANTING THE DEVICE IT BROKE. ALL BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770539 ↗
• MalfunctionJan 26, 2021Break

  IT WAS REPORTED THAT THE ANCHOR BROKE WHEN IMPACTED AND ONE PIECE HAS BEEN LEFT IN THE PATIENT. THE BROKEN OFF PIECE HAS NOT BEEN RETRIEVED AND WILL REMAIN IN THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 15-JAN-2021: THE SHOULDER ARTHROSCOPY TOOK PLACE ON (B)(6) 2020. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11228669 ↗
• InjuryAug 7, 2020Break

  AN ARTHREX EMPLOYEE HAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHORS BROKE INTO HALVE WHEN THEY WERE INSERTED. THE PART REMAINED INSIDE THE PATIENT AS IT WAS PROPERLY FIXATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10379173 ↗
• InjuryAug 7, 2020Break

  AN ARTHREX EMPLOYEE HAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHORS BROKE INTO HALVE WHEN THEY WERE INSERTED. THE PART REMAINED INSIDE THE PATIENT AS IT WAS PROPERLY FIXATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10379131 ↗