Arthrex® AR-2923PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867028036), received between May 9, 2017 and Jun 26, 2025 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Break; Break

  ON 06/04/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE INVOLVING AN AR-2923PS PEEK PUSHLOCK SL ANCHOR. THE ANCHOR HAD BEEN LOADED WITH TWO TAILS OF #2 FIBERWIRE, WHICH WERE PASSED AROUND THE LABRUM. A PILOT HOLE WAS DRILLED USING THE DRILL AND GUIDE FROM AN AR-1926DS, AND BOTH INSTRUMENTS WERE REMOVED PRIOR TO ANCHOR INSERTION. THE ANCHOR WAS THEN INTRODUCED THROUGH A GEMINI CANNULA IN THE ANTEROINFERIOR PORTAL. AS THE PUSHLOCK WAS ADVANCED INTO THE JOINT AND TENSION APPLIED TO THE SUTURE TO APPROXIMATE THE LABRAL TISSUE TO THE EYELET, THE EYELET BROKE OFF THE TIP OF THE PUSHLOCK, RENDERING THE IMPLANT UNUSABLE. THE CASE WAS DELAYED BY APPROXIMATELY 3 MINUTES WHILE TROUBLESHOOTING THE ANCHOR AND SWITCHING TO A DIFFERENT ANCHOR TO COMPLETE FIXATION. THIS WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22338066 ↗
• MalfunctionJun 26, 2025Break; Break

  ON 06/04/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE INVOLVING AN AR-2923PS PEEK PUSHLOCK SL ANCHOR. THE ANCHOR HAD BEEN LOADED WITH TWO TAILS OF # 2 FIBERWIRE, WHICH WERE PASSED AROUND THE LABRUM. AFTER A PILOT HOLE WAS DRILLED USING THE AR-1926DS DRILL AND GUIDE, BOTH INSTRUMENTS WERE REMOVED, AND THE ANCHOR WAS INSERTED THROUGH A GEMINI CANNULA IN THE ANTEROINFERIOR PORTAL. AS THE PUSHLOCK WAS ADVANCED INTO THE JOINT, TENSION WAS APPLIED TO APPROXIMATE THE LABRAL TISSUE TO THE EYELET. WHILE RELEASING THE SUTURE TAILS, THE DRIVER WAS GENTLY MALLETED TO ADVANCE IT INTO THE BONE SOCKET, AT WHICH POINT THE EYELET BROKE OFF THE TIP OF THE PUSHLOCK, RENDERING THE IMPLANT UNUSABLE. THE CASE WAS DELAYED BY APPROXIMATELY 5 MINUTES WHILE TROUBLESHOOTING THE ANCHOR AND ADDITIONAL DEVICES BEFORE SWITCHING TO FIBERTAK ANCHORS TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22337952 ↗
• MalfunctionJun 26, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON 06/04/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE INVOLVING AN AR-2923PS PEEK PUSHLOCK SL ANCHOR. THE ANCHOR WAS LOADED WITH TWO TAILS OF #2 FIBERWIRE, WHICH HAD BEEN PASSED AROUND THE LABRUM. FOLLOWING THE CREATION OF A PILOT HOLE USING THE DRILL AND GUIDE FROM AN AR-1926DS, THE INSTRUMENTS WERE REMOVED, AND THE ANCHOR WAS INSERTED THROUGH A GEMINI CANNULA IN THE ANTEROINFERIOR PORTAL. AS THE PUSHLOCK WAS ADVANCED INTO THE JOINT AND TENSION APPLIED TO APPROXIMATE THE LABRAL TISSUE TO THE EYELET, THE EYELET BROKE OFF THE TIP OF THE PUSHLOCK, RENDERING IT UNUSABLE. THE CASE WAS DELAYED BY APPROXIMATELY 10 MINUTES TO TROUBLESHOOT THE ISSUE WITH THE ANCHOR AND SUBSEQUENT DEVICES BEFORE SWITCHING TO FIBERTAK ANCHORS TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

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

  MAUDE report 22337854 ↗
• MalfunctionMay 19, 2025Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  ON 24 APRIL 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-3638H-1 KNOTLESS HIP FIBERTAK AND ONE AR-2923PS, SUTR ANCHPEEK P-LCK2.9X 12.5MM WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2025, DURING A RIGHT HIP ARTHROSCOPY & LABRAL REPAIR. IT WAS REPORTED SURGEON PERFORMING A LABRAL REPAIR OF RIGHT HIP. SURGEON USING KNOTLESS HIP FIBERTAK SUTURE ANCHORS. 2X ANCHORS DEPLOYED ALREADY INTO JOINT. STAFF OPENED A 3RD ANCHOR. UNFORTUNATELY, THE SUTURES HAD UNRAVELLED FROM THE INSERTER AND WERE UNABLE TO BE RE-POSITIONED ONTO THE INSERTER. A 4TH ANCHOR WAS THEN OPENED AND USED, AND UNFORTUNATELY PULLED STRAIGHT BACK OUT. ALL PIECES OF THE SUTURE ANCHOR REMOVED FROM THE JOINT. SURGEON THEN OPTED TO USE A HIP PUSHLOCK ANCHOR WITH 1.3MM SUTURE TAPE. UPON INSERTION, IT WAS NOTED THAT THE EYELET BROKE. LIKELY DUE TO SUBOPTIMAL TRAJECTORY ON INSERTION. THE ANCHOR WAS REMOVED WITH NO PIECES REMAINING IN JOINT. THE CASE WAS COMPLETED SUCCESSFULLY USING A STRYKER CINCLOCK. THERE WAS CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044027 ↗
• MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE EYELET DETACHED FROM THE APPLICATOR BEFORE FULL INSERTION AND COULD NOT BE SCREWED BACK ON THE DEVICES AR-2923PS (LOT: 15116072) MANUALLY. THE BROKEN OFF PARTS 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 18960773 ↗
• MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE EYELET DETACHED FROM THE APPLICATOR BEFORE FULL INSERTION AND COULD NOT BE SCREWED BACK ON THE DEVICES AR-2923PS (LOT: 15116072) MANUALLY. THE BROKEN OFF PARTS 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 18960737 ↗
• MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 03/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-2923PS SUTURE ANCHORS EYELET DISENGAGED. THIS OCCURRED DURING AN ANTERIOR LABRAL REPAIR ON (B)(6) 2024 WHILE TRYING TO LOAD THE PUSHLOCK, THE EYELET DISENGAGED MULTIPLE TIMES. UPON TRYING TO POSITION THE ANCHOR INTO THE SOCKET, AND THE EYELET DISENGAGED AGAIN. ADDITIONAL INFORMATION WAS PROVIDED ON 03/08/2024 WHERE THE SALES REPRESENTATIVE REPORTED THAT ALL FRAGMENTS WERE RECOVERED FROM THE PATIENT. A REUSABLE PUSHLOCK DRILL WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION. THE PATIENT HAD GOOD BONE QUALITY.

  Patient problems: Insufficient Information

  MAUDE report 18960500 ↗
• MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 03/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-2923PS SUTURE ANCHORS EYELET DISENGAGED. THIS OCCURRED DURING AN ANTERIOR LABRAL REPAIR ON (B)(6) 2024 WHILE TRYING TO LOAD THE PUSHLOCK, THE EYELET DISENGAGED MULTIPLE TIMES. UPON TRYING TO POSITION THE ANCHOR INTO THE SOCKET, AND THE EYELET DISENGAGED AGAIN. ADDITIONAL INFORMATION WAS PROVIDED ON 03/08/2024 WHERE THE SALES REPRESENTATIVE REPORTED THAT ALL FRAGMENTS WERE RECOVERED FROM THE PATIENT. A REUSABLE PUSHLOCK DRILL WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION. THE PATIENT HAD GOOD BONE QUALITY.

  Patient problems: Insufficient Information

  MAUDE report 18960480 ↗
• MalfunctionSep 11, 2023Break; Defective Device; Break; Defective Device

  ON 8/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2923PS PEEK PUSHLOCK FLAG WAS DETACHED FROM THE PUSHLOCK UPON OPENING IT. THE SUTURES AND ANCHORS APPEARED NORMAL, SO THE SURGEON INSERTED THE IMPLANT. WHEN THE PUSHLOCK WAS BEING UNSCREWED, IT WAS NOTICED THAT THE SUTURE TAPE HAD BEEN CUT, AND THE ANCHOR EYELET HAD PULLED OUT OF THE PREPARED BONE WHILE THE ANCHOR ITSELF REMAINED IMPLANTED. THE EYELET AND THE BROKEN SUTURES WERE RETRIEVED FROM INSIDE THE PATIENT. ANOTHER AR-2923PS PEEK PUSHLOCK WAS OPENED, AND IT WAS NOTICED AGAIN THAT THE FLAG WAS NOT CONNECTED. THE ANCHOR WAS NOT USED AS THE SURGEON WAS NOT WILLING TO RISK THE SAME OUTCOME AS THE PREVIOUS ANCHOR. THE CASE WAS COMPLETED WITH A THIRD AR-2923PS PEEK PUSHLOCK, WHICH HAD THE FLAG ATTACHED. THIS WAS DISCOVERED DURING A SHOULDER LABRAL REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 8/30/2023: THERE WAS A TEN-MINUTE DELAY WHILE THE SURGEON WAS DETERMINING WHETHER OR NOT TO IMPLANT THE SECOND FAULTY ANCHOR AND HOW TO CONTINUE THE CASE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT DUE TO THE DELAY. AFTER THE INCIDENTS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17724771 ↗
• MalfunctionSep 11, 2023Defective Device; Defective Device

  ON 8/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2923PS PEEK PUSHLOCK FLAG WAS DETACHED FROM THE PUSHLOCK UPON OPENING IT. THE SUTURES AND ANCHORS APPEARED NORMAL, SO THE SURGEON INSERTED THE IMPLANT. WHEN THE PUSHLOCK WAS BEING UNSCREWED, IT WAS NOTICED THAT THE SUTURE TAPE HAD BEEN CUT, AND THE ANCHOR EYELET HAD PULLED OUT OF THE PREPARED BONE WHILE THE ANCHOR ITSELF REMAINED IMPLANTED. THE EYELET AND THE BROKEN SUTURES WERE RETRIEVED FROM INSIDE THE PATIENT. ANOTHER AR-2923PS PEEK PUSHLOCK WAS OPENED, AND IT WAS NOTICED AGAIN THAT THE FLAG WAS NOT CONNECTED. THE ANCHOR WAS NOT USED AS THE SURGEON WAS NOT WILLING TO RISK THE SAME OUTCOME AS THE PREVIOUS ANCHOR. THE CASE WAS COMPLETED WITH A THIRD AR-2923PS PEEK PUSHLOCK, WHICH HAD THE FLAG ATTACHED. THIS WAS DISCOVERED DURING A SHOULDER LABRAL REPAIR PROCEDURE ON (B)(6) 2023.ADDITIONAL INFORMATION RECEIVED ON 8/30/2023:THERE WAS A TEN-MINUTE DELAY WHILE THE SURGEON WAS DETERMINING WHETHER OR NOT TO IMPLANT THE SECOND FAULTY ANCHOR AND HOW TO CONTINUE THE CASE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT DUE TO THE DELAY. AFTER THE INCIDENTS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17721340 ↗
• MalfunctionNov 14, 2022Difficult to Insert; Detachment of Device or Device Component

  ON 10/25/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2923PS PEEK PUSHLOCK EYELET CAME OFF WHILE BEING INSERTED USING A MALLET. SURGEON REMOVED IT WITH A GRASPER, REINSERTED THE EYELET TO THE TIP OF THE ANCHOR, AND WITH THE MALLET, ATTEMPTED TO IMPLANT IT ONE MORE TIME BECAUSE IT SEEMED STABLE. HOWEVER, THE EYELET CAME OFF THE ANCHOR AGAIN. SURGEON REMOVED THE EYELET WITH GRASPER AND USED ANOTHER AR-2923PS PEEK PUSHLOCK TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788176 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2923PS PEEK PUSHLOCK AND AN AR-7500 SUTURETAPE WAS IMPLANTED SUCCESSFULLY INTO PATIENT DURING AN ARTHROSCOPY RIGHT SHOULDER WITH CAPSULORRHAPHY. AFTER THE PROCEDURE THE PATIENT COMPLAINT OF PAIN AND TIGHTNESS AND SINCE THE PROCEDURE, PATIENT WAS NOT PROGRESSING WITH PHYSICAL THERAPY. PATIENT WAS REFERRED FOR A SECOND OPINION AND HAD ANOTHER ARTHROSCOPY PROCEDURE. DURING THE PROCEDURE, SURGEON DISCOVERED THE TISSUE SURROUNDING THE ANCHORS TO BE RED AND INFLAMED. THE ANCHORS WERE REMOVED ALONG WITH THE SURROUNDING IRRITATED TISSUES. PATIENT HAS A KNOWN ALLERGY TO NEOPRENE.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 13569467 ↗
• MalfunctionFeb 7, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-2923PS SUTURE ANCHORS EYELET BROKE. THIS OCCURRED DURING A BANKART REPAIR THE SURGEON WAS TENSIONING THE SUTURE FOR THE PUSHLOCK ANCHOR AND ALL OF A SUDDEN THE SUTURE WAS NO LONGER IN THE DRILL TUNNEL. THE SURGEON PULLED THE ANCHOR OUT AND NOTICED THAT THE EYELET HAD BROKEN AND THE SUTURE WOULD NOT REMAIN IN THE EYELET. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED USING A NEW AR-2923PS SUTURE ANCHOR FROM A DIFFERENT LOT. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED ON 12/14/2021 : A AR-2923DS WAS USED TO PREPARE THE BONE SOCKET. THE BONE QUALITY OF THE PATIENT WAS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 13471238 ↗
• MalfunctionFeb 11, 2021Break

  IT WAS REPORTED, THAT THE EYELET DISENGAGED FROM THE ANCHOR (AR-2923PS, LOT 10318889) ONCE FULLY INSERTED. THE PIECE BROKE OF INSIDE THE PATIENT, BUT WAS RETRIEVED FROM THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE ARTHROSCOPIC LABRAL STABILIZATION SHOULDER SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. THE SURGEON HAD TO SWITCH THE SURGICAL TECHNIQUE TO A 3MM SUTURETAK. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313972 ↗
• MalfunctionFeb 11, 2021Break

  IT WAS REPORTED THAT DURING LABRUM RE-FIX SURGERY THE DEVICE DID BREAK OFF WHILE INSERTING. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313935 ↗
• InjurySep 15, 2020Break

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW509611) THAT THE FOLLOWING INCIDENT WAS REPORTED BY A FACILITY: ¿A PATIENT HAD SCHEDULED OUTPATIENT RIGHT SHOULDER ARTHROSCOPY WITH REPAIR IN 2020. AT RETURN VISIT TO PROVIDER AN X-RAY NOTED A FOREIGN BODY IN THE RIGHT SHOULDER. PATIENT HAD A SECOND PROCEDURE TO REMOVE THE FOREIGN BODY. FOREIGN BODY SUSPECTED TO BE BROKEN INSERTER DEVICE FOR A KNOTLESS FIBERTAK ANCHOR FROM ARTHREX. MANUFACTURER INFORMATION DOES INDICATE THAT THE ANCHOR INSERTION EQUIPMENT CAN BREAK DURING THE APPLICATION PROCESS. THIS IS NOT PART OF THE SURGICAL COUNT. SO IT WOULD NOT HAVE BEEN DETECTED DURING OR AT THE CONCLUSION OF THE PROCEDURE. IT WOULD HAVE NOT BEEN EVIDENT TO THE SURGEON AT THE ANCHOR PLACEMENT THAT THERE WAS A BREAKAGE.¿ THE FDA MEDWATCH LETTER ALSO LISTED THE FOLLOWING ARTHREX DEVICES UNDER CONCOMITANT MEDICAL PRODUCTS: ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK , MODEL AR-3638, LOT 10860295, EXP 3/31/2025. ANCHOR BONE 2.9 PEEK PUSHLOCK, MODEL AR-2923PS, LOT 10538126, EXP 11/30/2024. ANCHOR BONE 2.9 PEEK PUSHLOCK, MODEL AR-2923PS, LOT 10538124, EXP 11/30/2024. ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK, MODEL AR-3638, LOT 10654070, EXP 1/31/2025 (B)(4). ANCHOR S

  Patient problems: Foreign Body In Patient

  MAUDE report 10537588 ↗
• InjurySep 15, 2020Break

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW509611) THAT THE FOLLOWING INCIDENT WAS REPORTED BY A FACILITY: ¿A PATIENT HAD SCHEDULED OUTPATIENT RIGHT SHOULDER ARTHROSCOPY WITH REPAIR IN 2020. AT RETURN VISIT TO PROVIDER AN X-RAY NOTED A FOREIGN BODY IN THE RIGHT SHOULDER. PATIENT HAD A SECOND PROCEDURE TO REMOVE THE FOREIGN BODY. FOREIGN BODY SUSPECTED TO BE BROKEN INSERTER DEVICE FOR A KNOTLESS FIBERTAK ANCHOR FROM ARTHREX. MANUFACTURER INFORMATION DOES INDICATE THAT THE ANCHOR INSERTION EQUIPMENT CAN BREAK DURING THE APPLICATION PROCESS. THIS IS NOT PART OF THE SURGICAL COUNT. SO IT WOULD NOT HAVE BEEN DETECTED DURING OR AT THE CONCLUSION OF THE PROCEDURE. IT WOULD HAVE NOT BEEN EVIDENT TO THE SURGEON AT THE ANCHOR PLACEMENT THAT THERE WAS A BREAKAGE.¿ THE FDA MEDWATCH LETTER ALSO LISTED THE FOLLOWING ARTHREX DEVICES UNDER CONCOMITANT MEDICAL PRODUCTS: ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR-3638 LOT 10860295 EXP 3/31/2025. ANCHOR BONE 2.9 PEEK PUSHLOCK MODEL AR-2923PS LOT 10538126 EXP 11/30/2024. ANCHOR BONE 2.9 PEEK PUSHLOCK MODEL AR-2923PS LOT 10538124 EXP 11/30/2024. ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR-3638 LOT 10654070 EXP 1/31/2025 (QTY 2). ANCHOR SUTURE 1.8 KN

  Patient problems: Foreign Body In Patient

  MAUDE report 10537576 ↗
• InjuryAug 20, 2020Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROSCOPIC LABRAL REPAIR (BANKART REPAIR 3 TO 6 O'CLOCK) PROCEDURE DURING WHICH THE FOLLOWING ARHREX DEVICES WERE IMPLANTED USING THE INSERTERS THAT COME WITH THE DEVICES: ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR-3638 (LOT 10860295), ANCHOR BONE 2.9 PEEK PUSHLOCK MODEL AR-2923PS (LOT 10538126), ANCHOR BONE 2.9 PEEK PUSHLOCK MODEL AR-2923PS (LOT 10538124), ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR 3638 (LOT 10654070) - QTY 2, ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR-3638 (LOT 10668916). THE INSERTER PART OF THE DEVICES WERE DISCARDED AT THE TIME OF THE PROCEDURE. POST-OP THE PATIENT WAS EXPERIENCING NIGHT PAIN AND IT WAS DISCOVERED THAT A FOREIGN BODY WAS IN THE PATIENT. THE SAME SURGEON PERFORMED A SECOND SURGERY (B)(6) 2020, AT THE SAME FACILITY, TO REMOVE THE FOREIGN BODY. THE FACILITY IS UNABLE TO DETERMINE WHICH OF THE SIX INSERTER DEVICES THE FOREIGN BODY MAY HAVE COME FROM AS THEY ARE NO LONGER AVAILABLE TO EXAMINE. THE FACILITY RISK MANAGER HAS CONFIRMED THAT THE FACILITY WILL NOT BE RELEASING THE DEVICE BUT HAS CONFIRMED THE FRAGMENT WILL BE PRESERVED WITH LENGTH OF TIME PENDING RECOMMENDATION FOR THE FA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10431351 ↗
• InjuryAug 20, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROSCOPIC LABRAL REPAIR (BANKART REPAIR 3 TO 6 O'CLOCK) PROCEDURE DURING WHICH THE FOLLOWING ARHREX DEVICES WERE IMPLANTED USING THE INSERTERS THAT COME WITH THE DEVICES: ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR-3638 (LOT 10860295), ANCHOR BONE 2.9 PEEK PUSHLOCK MODEL AR-2923PS (LOT 10538126), ANCHOR BONE 2.9 PEEK PUSHLOCK MODEL AR-2923PS (LOT 10538124), ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR 3638 (LOT 10654070) - QTY 2, ANCHOR SUTURE 1.8 KNOTLESS FIBERTAK MODEL AR-3638 (LOT 10668916). THE INSERTER PART OF THE DEVICES WERE DISCARDED AT THE TIME OF THE PROCEDURE. POST-OP THE PATIENT WAS EXPERIENCING NIGHT PAIN AND IT WAS DISCOVERED THAT A FOREIGN BODY WAS IN THE PATIENT. THE SAME SURGEON PERFORMED A SECOND SURGERY (B)(6) 2020, AT THE SAME FACILITY, TO REMOVE THE FOREIGN BODY. THE FACILITY IS UNABLE TO DETERMINE WHICH OF THE SIX INSERTER DEVICES THE FOREIGN BODY MAY HAVE COME FROM AS THEY ARE NO LONGER AVAILABLE TO EXAMINE. THE FACILITY RISK MANAGER HAS CONFIRMED THAT THE FACILITY WILL NOT BE RELEASING THE DEVICE BUT HAS CONFIRMED THE FRAGMENT WILL BE PRESERVED WITH LENGTH OF TIME PENDING RECOMMENDATION FOR THE FA

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 10431344 ↗
• InjuryMay 9, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LABRUM REPAIR ON HER LEFT SHOULDER ON (B)(6) 2016. ABOUT 2 WEEKS POST-OP, SHE STARTED TO NOTICE HIVES ON HER LEFT SHOULDER. SHE INFORMED HER SURGEON, WHO ADVISED HER TO SEE HER FAMILY DOCTOR. SHE WAS PRESCRIBED PREDNISONE AND ADORAC AND HAS ALSO BEEN APPLYING AN ANTI-ITCH CREAM TO ALLEVIATE THE SYMPTOMS OF THE HIVES. THE HIVES COME AND GO, START AT THE SURGERY SITE AND SPREADS UP TO THE BACK OF HER NECK. ALLERGY TESTS HAVE BEEN TAKEN WITH NEGATIVE RESULTS. THE PATIENT HAS A TOTAL OF 3 PUSHLOCKS IN HER SHOULDER, AR-2923PS LOT 1138636 QTY 1 ((B)(4)) AND AR-2923 LOT 895132 QTY 2 ((B)(4)).

  Patient problems: Skin Irritation

  MAUDE report 6555589 ↗
• InjuryMay 9, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LABRUM REPAIR ON HER LEFT SHOULDER ON (B)(6) /2016. ABOUT 2 WEEKS POST-OP, SHE STARTED TO NOTICE HIVES ON HER LEFT SHOULDER. SHE INFORMED HER SURGEON, WHO ADVISED HER TO SEE HER FAMILY DOCTOR. SHE WAS PRESCRIBED PREDNISONE AND ADORAC AND HAS ALSO BEEN APPLYING AN ANTI-ITCH CREAM TO ALLEVIATE THE SYMPTOMS OF THE HIVES. THE HIVES COME AND GO, START AT THE SURGERY SITE AND SPREADS UP TO THE BACK OF HER NECK. ALLERGY TESTS HAVE BEEN TAKEN WITH NEGATIVE RESULTS. THE PATIENT HAS A TOTAL OF 3 PUSHLOCKS IN HER SHOULDER, AR-2923PS LOT 1138636 QTY 1 ((B)(4)) AND AR-2923 LOT 895132 QTY 2 ((B)(4)).

  Patient problems: Skin Irritation

  MAUDE report 6555576 ↗