Arthrex® AR-1923BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00888867023017), received between Apr 25, 2017 and Sep 11, 2026 — classified as 8 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (53 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Separation

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 50735204 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY, A PART OF THE IMPLANT BROKE OFF. THE BROKEN PIECE WAS 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 24639480 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY, A PART OF THE IMPLANT BROKE OFF. THE BROKEN PIECE WAS 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 24639354 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE ANCHORS BROKE DURING INSERTION. 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 24485137 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE ANCHORS BROKE DURING INSERTION. 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 24485012 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE ANCHORS BROKE DURING INSERTION. 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 24484671 ↗
• MalfunctionFeb 19, 2026Break

  ON 3RD FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1923BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 2.9 X 15.5 MM, WHEN INSTALLING THE EXTERNAL SCREWS, THE SUTURE WAS PROPERLY PRESSED. THE FIBULA WAS VERY HARD AND DURING THE PRESSING PROCESS, THE EXTERNAL SCREW WAS COMPLETELY BROKEN. THIS WAS DETECTED DURING AN ANKLE LIGAMENT REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1923BC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387971 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPIC LABRAL REPAIR, THE ANCHOR BROKE INSIDE THE PATIENT. SOME OF THE FRAGMENTS WERE REMOVED FROM THE PATIENT, BUT PART OF THEM REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. UPDATE 13-FEB-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE SHOULDER BANKART/ SLAP REPAIR, THAT ONE ANCHOR DID NOT BREAK BUT THE EYELET BROKE OFF IN THE SOCKET AND REMAINED INSIDE THE PATIENT. THE SECOND ANCHOR (SAME PART NUMBER AND BATCH) BROKE INTO TWO PIECES BUT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT SUFFERED A GLENOID FRACTURE DURING IMPLANTATION OF THE ANCHORS. THE SMALL GLENOID FRACTURE DID NOT REQUIRE TREATMENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE AND NO SECOND SURGERY IS PLANNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24344432 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPIC LABRAL REPAIR, THE ANCHOR BROKE INSIDE THE PATIENT. SOME OF THE FRAGMENTS WERE REMOVED FROM THE PATIENT, BUT PART OF THEM REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24315068 ↗
• MalfunctionNov 13, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547087 ↗
• MalfunctionNov 13, 2025Break; Break

  ON 10/22/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547082 ↗
• MalfunctionNov 13, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547081 ↗
• MalfunctionNov 13, 2025Break; Break

  ON 10/22/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547079 ↗
• MalfunctionNov 13, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547069 ↗
• MalfunctionNov 13, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547066 ↗
• MalfunctionOct 27, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/24/2025: THIS WAS DISCOVERED DURING A GLENOHUMERAL INSTABILITY PROCEDURE. THE CASE WAS DELAYED FOR ABOUT FIFTEEN MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23393177 ↗
• MalfunctionOct 16, 2025Failure to Advance; Failure to Advance

  ON 10/08/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1923BC BIOCOMPOSITE PUSHLOCK SCREW FRACTURED INTO MULTIPLE PIECES, LEAVING IT CRACKED ON ALL SIDES. DURING THE PROCEDURE, TWO AR-1923BC BIOCOMPOSITE PUSHLOCK ANCHORS WERE SUCCESSFULLY PLACED. WHEN ATTEMPTING TO PLACE A THIRD ANCHOR, WHICH WAS FROM A DIFFERENT LOT THAN THE PREVIOUS TWO, THE SAME STANDARD PLACEMENT TECHNIQUE WAS USED. THE SURGEON POSITIONED THE PURPLE GUIDE, THE PUNCH WAS REMOVED, AND THE GUIDE WAS IMPACTED TO SECURE IT IN PLACE. DRILLING WAS PERFORMED TO THE STOP USING A 2.9 MM DRILL BIT. THE LABRAL TAPE ENDS WERE THREADED, AND THE GUIDE WAS REMOVED TO ALLOW INSERTION OF THE ANCHOR. UPON INITIAL IMPACT TO INSERT THE ANCHOR, IT FRACTURED INTO SEVERAL PIECES. ALTHOUGH THE ANCHOR WAS IMPACTED TO THE INTENDED DEPTH, IT FAILED STRUCTURALLY AND WAS REMOVED. THE CASE WAS COMPLETED USING A PEEK ANCHOR AS A REPLACEMENT. IT WAS NOTED THAT THE SURGEON MAINTAINED FIRM CONTROL OF THE HANDLE THROUGHOUT THE PLACEMENT TO ENSURE PROPER ALIGNMENT. THIS EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23312626 ↗
• MalfunctionAug 27, 2025Break; Break

  ON 11TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-1923BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 2.9 X 15.5 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1923BC. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906578 ↗
• MalfunctionJun 26, 2025Break; Break

  ON 04 JUN 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1923BC SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 2.9 X 15.5 MM, EYELET DETACHED AFTER INSERTION AND BROKE DURING USE. THIS WAS DISCOVERED BY THE CUSTOMER DURING A PROCEDURE. A NEW IMPLANT WAS USED TO COMPLETE THE CASE SUCCESSFULLY AS THE FIRST IMPLANT CANNOT FULFILL ITS PURPOSE.

  Patient problems: Insufficient Information

  MAUDE report 22336005 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION BANKART LESION SURGERY THE ANCHOR AR-1923BC (LOT: 15244879) BROKE APART DURING INSERTION. 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 20586373 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION BANKART LESION SURGERY THE ANCHOR AR-1923BC (LOT: 15244879) BROKE APART DURING INSERTION. 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 20586329 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION BANKART LESION SURGERY THE ANCHOR AR-1923BC (LOT: 15244879) BROKE APART DURING INSERTION. 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 20586282 ↗
• MalfunctionOct 16, 2024Break; Break

  ON 10/8/2024 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT TWO AR-1923BC BIOCOMPOSITE PUSHLOCK EYELETS WERE DAMAGED, AND THE SUTURES GOT LOOSENED. ONE OF THE AR-1923BC BIOCOMPOSITE PUSHLOCK EYELETS ENDED UP FULLY BREAKING WHILE IT WAS INSIDE THE PATIENT, AND THE OTHER BIOCOMPOSITE PUSHLOCK WAS NOTICED TO BE BROKEN PRIOR TO INSERTION. THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461749 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE ANCHOR BENT AND BROKE RIGHT AT THE BEGINNING DURING INSERTION. ALL 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 20397289 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE ANCHOR BROKE. 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 20260782 ↗