Arthrex® AR-1926PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867023338), received between Mar 13, 2017 and Dec 17, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1926PS, SUTURE ANCHOR, PUSHLOCK® 3.5 X 19.5 MM, THE FIRST UNIT OF AR-1926PS BROKE AND THE SECOND UNIT OF AR-1926PS COULD NOT BE FIXED DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A 3RD AR-1926PS. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826357 ↗
• MalfunctionDec 8, 2025Positioning Failure; Positioning Failure

  ON 18TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1926PS, SUTURE ANCHOR, PUSHLOCK® 3.5 X 19.5 MM, THE FIRST UNIT OF AR-1926PS BROKE AND THE SECOND UNIT OF AR-1926PS COULD NOT BE FIXED DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A 3RD AR-1926PS. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741782 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE ANCHOR OF THE DEVICE BROKE 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 20418347 ↗
• MalfunctionSep 14, 2023Break; Break

  ON 08/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1926PS PUSHLOCK ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17744335 ↗
• InjuryDec 17, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RCR PROCEDURE ON (B)(6) 2019 WHERE A PEEK CORKSCREW SUTURE ANCHOR, AR-1927PSF, AND A PUSHLOCK SUTURE ANCHOR, AR-1926PS, WERE IMPLANTED. THE SURGERY WAS COMPLETED WITH NO ISSUES. ABOUT TWO WEEKS LATER, THE PATIENT PRESENTED WITH PAIN IN THEIR SHOULDER IN THE GENERAL JOINT. THE SURGEON DECIDED TO REMOVE THE IMPLANTS AS THE PATIENT MAY HAVE HAD AN INFECTION. DURING THE REVISION, THE MEDIAL IMPLANT WAS FOUND TO BE A LITTLE LOOSE BUT DID NOT APPEAR TO BE INFECTED. BOTH IMPLANTS EXPLANTED AND THE SURGEON DID NOT REPLACE THEM WITH ANY HARDWARE. THE SURGEON SENT THE IMPLANTS TO PATHOLOGY FOR CULTURES AND FLUSHED THE JOINT. RESULTS FROM THE CULTURES WILL BE PROVIDED ONCE AVAILABLE. ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT. PATIENT IS A MALE, (B)(6).

  Patient problems: Pain

  MAUDE report 9482955 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem

  AN INITIAL CONTACT WAS RECEIVED THROUGH THE ARTHREX WEBSITE REQUESTING A CONTACT PERSON REGARDING POST-OPERATIVE INFECTIONS INVOLVING ARTHREX PRODUCTS. UPON FURTHER INVESTIGATION IT HAS BEEN DISCOVERED THAT A PATIENT HAD LEFT SHOULDER ARTHROSCOPY-ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: ARTHREX SUTURE ANCHOR PEEK CORKSCREW FT 4.5X14MM X2(AR-1927PSF-45, LOT: F200079 AND LOT: F185845) AND SUTURE ANCHOR PUSHLOCK 3.5X19.5MM X3(AR-1926PS, LOT: 10194738). DURING PATIENT OFFICE VISIT ON (B)(6) 2018 PATIENT REPORTED POSSIBLE REACTION TYPE SYMPTOM. THE SYMPTOMS INCLUDED: ERYTHEMA, PAIN AND TENDERNESS. THE PATIENT HAS BEEN TREATED WITH PO ANTIBIOTICS, AND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS. TESTING HAS BEEN PERFORMED HOWEVER TO DATE ALL CULTURES HAVE BEEN REPORTED AS NEGATIVE, INCLUDING P-ACNES. ADDITIONAL INFORMATION OBTAINED 9/11/2018: THE DATE OF THE SECOND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS WAS (B)(6) 2018. THE SURGERY WAS PERFORMED AT A DIFFERENT FACILITY THAN THE ORIGINAL PROCEDURE. THE EXPLANTED ANCHORS ARE REPORTED TO H

  Patient problems: Erythema; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 7902505 ↗
• InjuryJun 27, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR ON (B)(6) 2017 WHERE A BIO-COMPOSITE SWIVELOCK TENODESIS SUTURE ANCHOR, AR-1662BC-7 (CC116304, LINE 195529) WAS IMPLANTED INTO THE PATIENT'S SHOULDER. APPROXIMATELY FOUR DAYS AFTER THE SURGERY, THE PATIENT BEGAN TO EXPERIENCE TROUBLE BREATHING AND SWELLING IN THE THROAT. THE PATIENT HAS BEEN TREATED AT THE ER FOR SYMPTOMS. NO REDNESS OR SWELLING CAN BE SEEN AT THE SURGERY SITE. THE PATIENT CLAIMS THEY HAVE NEVER HAD ANY ISSUES OF THIS NATURE UNTIL AFTER THEIR PROCEDURE. THE PATIENT'S ONLY KNOWN ALLERGY IS PENICILLIN. THE BELOW PART NUMBERS WERE ALSO IMPLANTED ON (B)(6). AR-1662BC LOT 10110092 1EA (CC116304, LINE 197799), AR-1927PSF LOT 10068319 1EA (CC116304, LINE 197800), AR-1926PS LOT 10064848 1EA (CC116304, LINE 197801) AND AR-1926PS LOT 10053400 1EA (CC116304, LINE 197802).

  Patient problems: Respiratory Distress; Swelling

  MAUDE report 6671298 ↗
• InjuryJun 27, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR ON (B)(6) 2017 WHERE A BIO-COMPOSITE SWIVELOCK TENODESIS SUTURE ANCHOR, AR-1662BC-7 (CC116304, LINE 195529) WAS IMPLANTED INTO THE PATIENT'S SHOULDER. APPROXIMATELY FOUR DAYS AFTER THE SURGERY, THE PATIENT BEGAN TO EXPERIENCE TROUBLE BREATHING AND SWELLING IN THE THROAT. THE PATIENT HAS BEEN TREATED AT THE ER FOR SYMPTOMS. NO REDNESS OR SWELLING CAN BE SEEN AT THE SURGERY SITE. THE PATIENT CLAIMS THEY HAVE NEVER HAD ANY ISSUES OF THIS NATURE UNTIL AFTER THEIR PROCEDURE. THE PATIENT'S ONLY KNOWN ALLERGY IS PENICILLIN. THE BELOW PART NUMBERS WERE ALSO IMPLANTED ON (B)(6). AR-1662BC LOT 10110092 1EA (CC116304, LINE 197799), AR-1927PSF LOT 10068319 1EA (CC116304, LINE 197800), AR-1926PS LOT 10064848 1EA (CC116304, LINE 197801) AND AR-1926PS LOT 10053400 1EA (CC116304, LINE 197802).

  Patient problems: Respiratory Distress; Swelling

  MAUDE report 6671292 ↗
• InjuryMar 13, 2017Insufficient Device Problem Information

  A PATIENT SUBMITTED A REQUEST THROUGH THE ARTHREX WEBSITE FOR MATERIAL COMPOSITION OF THE ARTHREX BIO FASTAC SCREW AND PUSH LOCK ANCHORS. PATIENT IS SEEKING MATERIAL COMPOSITION BECAUSE THE PRODUCTS WERE USED IN HER SHOULDER SURGERY. RECENT TESTS SHOW SHE IS ALLERGIC TO NICKEL AND MANY OTHER PRODUCTS AND PATIENT STATES SHE MAY HAVE TO HAVE THE IMPLANTS REMOVED. **ADDITIONAL INFORMATION OBTAINED 2/17/2017: PATIENT'S SURGERY WAS A LEFT SLAP LESION TYPE 2 PROCEDURE WHICH TOOK PLACE (B)(6) 2006. PATIENT HAS BEEN EXPERIENCING PAIN, BURNING AND ACHING SINCE DAY AFTER SURGERY. NO CULTURES HAVE BEEN TAKEN AND SHE HAS BEEN TREATED WITH PAIN MEDS FOR THE SYMPTOMS. NO REVISION SURGERY HAS BEEN PLANNED. DURING THE (B)(6) 2006 PROCEDURE PATIENT STATES THE FOLLOWING ARTHREX SCREWS WERE IMPLANTED: AR-1926PS PUSHLOCK, LOT 95580 (QTY 2) ((B)(4)), AR-1926PS PUSHLOCK, LOT 102736 (QTY 1) ((B)(4)) AND A BIOFASTAC SCREW 3.5 MM (SPECIFIC PART/LOT NUMBER NOT PROVIDED - UNABLE TO LOCATE POSSIBLE PRODUCT SALE TO FACILITY).

  Patient problems: Burning Sensation; Pain; Toxicity

  MAUDE report 6398547 ↗
• InjuryMar 13, 2017Adverse Event Without Identified Device or Use Problem

  A PATIENT SUBMITTED A REQUEST THROUGH THE ARTHREX WEBSITE FOR MATERIAL COMPOSITION OF THE ARTHREX BIO FASTAC SCREW AND PUSH LOCK ANCHORS. PATIENT IS SEEKING MATERIAL COMPOSITION BECAUSE THE PRODUCTS WERE USED IN HER SHOULDER SURGERY. RECENT TESTS SHOW SHE IS ALLERGIC TO NICKEL AND MANY OTHER PRODUCTS AND PATIENT STATES SHE MAY HAVE TO HAVE THE IMPLANTS REMOVED. **ADDITIONAL INFORMATION OBTAINED 2/17/2017: PATIENT'S SURGERY WAS A LEFT SLAP LESION TYPE 2 PROCEDURE WHICH TOOK PLACE (B)(6) 2006. PATIENT HAS BEEN EXPERIENCING PAIN, BURNING AND ACHING SINCE DAY AFTER SURGERY. NO CULTURES HAVE BEEN TAKEN AND SHE HAS BEEN TREATED WITH PAIN MEDS FOR THE SYMPTOMS. NO REVISION SURGERY HAS BEEN PLANNED. DURING THE (B)(6) 2006 PROCEDURE PATIENT STATES THE FOLLOWING ARTHREX SCREWS WERE IMPLANTED: AR-1926PS PUSHLOCK, LOT 95580 (QTY 2) ((B)(4)), AR-1926PS PUSHLOCK, LOT 102736 (QTY 1) ((B)(4)) AND A BIOFASTAC SCREW 3.5 MM (SPECIFIC PART/LOT NUMBER NOT PROVIDED - UNABLE TO LOCATE POSSIBLE PRODUCT SALE TO FACILITY).

  Patient problems: Burning Sensation; Pain; Reaction

  MAUDE report 6398541 ↗