Arthrex® AR-1928SF-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867023703), received between Dec 14, 2016 and Mar 24, 2026 — classified as 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Patient Device Interaction Problem

  ON 27-FEB-2026, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. ACCORDING TO THE REPORT, TWO AR-1928SF-2 CORKSCREW FT ANCHORS WERE IMPLANTED DURING A SURGICAL PROCEDURE ON (B)(6) 2024 TO REATTACH THE PATIENT'S HAMSTRING. THE WOUND INITIALLY HEALED; HOWEVER, OVER THE NEXT 18 MONTHS, THE PATIENT CONTINUED TO EXPERIENCE PAIN AND DEVELOPED A LUMP THAT WAS WARM TO THE TOUCH. MRI AND ADDITIONAL TESTING IDENTIFIED A STAPHYLOCOCCUS LUGDUNENSIS INFECTION, WHICH WAS SUBSEQUENTLY TREATED WITH IRRIGATION AND DEBRIDEMENT. THE PATIENT BELIEVES THE INFECTION HAS RECURRED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 16-MAR-2026: THE INITIAL SURGERY OCCURRED ON (B)(6) 2024. IN ADDITION TO THE TWO AR-1928SF-2 CORKSCREW FT ANCHORS, THE PATIENT REPORTED THAT ADDITIONAL AR-1928SF-2 CORKSCREW FT WAS ALSO USED. THE PATIENT STATED THAT SYMPTOMS FIRST BEGAN ON (B)(6) 2025, PRESENTING AS INCREASED PAIN DURING EXERCISE, PARTICULARLY WITH UNILATERAL RIGHT-LEG ACTIVITIES. THE PATIENT RETURNED TO THE PROVIDER AGAIN ON (B)(6) 2025 AFTER DEVELOPING AN 8-WEEK HISTORY OF A PALPABLE LUMP, PAINFUL SWELLING, AND WARMTH OVER THE REPAIR SITE, ALONG WITH INCREASED DISCOMFORT WHILE SITTING

  Patient problems: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 24680423 ↗
• InjuryMar 20, 2026Patient Device Interaction Problem

  ON 27-FEB-2026, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. ACCORDING TO THE REPORT, TWO AR-1928SF-2 CORKSCREW FT ANCHORS WERE IMPLANTED DURING A SURGICAL PROCEDURE ON (B)(6) 2024 TO REATTACH THE PATIENT'S HAMSTRING. THE WOUND INITIALLY HEALED; HOWEVER, OVER THE NEXT 18 MONTHS, THE PATIENT CONTINUED TO EXPERIENCE PAIN AND DEVELOPED A LUMP THAT WAS WARM TO THE TOUCH. MRI AND ADDITIONAL TESTING IDENTIFIED A STAPHYLOCOCCUS LUGDUNENSIS INFECTION, WHICH WAS SUBSEQUENTLY TREATED WITH IRRIGATION AND DEBRIDEMENT. THE PATIENT BELIEVES THE INFECTION HAS RECURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24649163 ↗
• InjuryMar 20, 2026Patient Device Interaction Problem

  ON 27-FEB-2026, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. ACCORDING TO THE REPORT, TWO AR-1928SF-2 CORKSCREW FT ANCHORS WERE IMPLANTED DURING A SURGICAL PROCEDURE ON (B)(6) 2024 TO REATTACH THE PATIENT'S HAMSTRING. THE WOUND INITIALLY HEALED; HOWEVER, OVER THE NEXT 18 MONTHS, THE PATIENT CONTINUED TO EXPERIENCE PAIN AND DEVELOPED A LUMP THAT WAS WARM TO THE TOUCH. MRI AND ADDITIONAL TESTING IDENTIFIED A STAPHYLOCOCCUS LUGDUNENSIS INFECTION, WHICH WAS SUBSEQUENTLY TREATED WITH IRRIGATION AND DEBRIDEMENT. THE PATIENT BELIEVES THE INFECTION HAS RECURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24648909 ↗
• MalfunctionSep 19, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON 09/01/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1928SF-2 AND AN AR-2323PSLC SUTURE ANCHOR EXPERIENCED ANCHOR FAILURE DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23095160 ↗
• MalfunctionJun 18, 2025Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TITANIUM ANCHORS ARE TORN OUT RESPECTIVELY THE SUTURES ARE RIPPED. 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 22283746 ↗
• MalfunctionJun 18, 2025Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TITANIUM ANCHORS ARE TORN OUT RESPECTIVELY THE SUTURES ARE RIPPED. 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 22283633 ↗
• MalfunctionJun 18, 2025Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TITANIUM ANCHORS ARE TORN OUT RESPECTIVELY THE SUTURES ARE RIPPED. 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 22283370 ↗
• MalfunctionDec 31, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A CORKSCREW FIXING SURGERY WHILE INSERTING THE ANCHOR THE HANDLE DID COME LOOSE FROM THE SCREW BEFORE IT WAS FULLY INSERTED INTO THE BONE. 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 21046898 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATE AVOE 23-OCT-2024. FURTHER INFORMATION WAS PROVIDED THAT DURING THE INITIAL SURGERY A REMOVAL OF A HAGLUND'S EXOSTOSIS AND AN OPEN REINSERTION OF THE ACHILLES TENDON IN A DEGENERATIVE RUPTURE WAS PERFORMED USING THE REPORTED DEVICES AR-1928SF-2 (LOT: 14743165). 6 WEEKS POSTOPERATIVELY WITHOUT FURTHER TRAUMA A MATERIAL FAILURE OF THE DEVICES OCCURRED, SO THAT A NEW OPERATION WAS NECESSARY. INTRAOPERATIVELY, THE SUTURES ALL APPEARED TO BE NO LONGER CONNECTED TO THE TITANIUM ANCHORS, ALTHOUGH THESE HAD NOT BEEN TORN OUT IN THE AREA OF THE TENDON.

  Patient problems: Failure of Implant

  MAUDE report 20419038 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATE AVOE (B)(6) 2024. FURTHER INFORMATION WAS PROVIDED THAT DURING THE INITIAL SURGERY A REMOVAL OF A HAGLUND'S EXOSTOSIS AND AN OPEN REINSERTION OF THE ACHILLES TENDON IN A DEGENERATIVE RUPTURE WAS PERFORMED USING THE REPORTED DEVICES AR-1928SF-2 (LOT: 14743165). 6 WEEKS POSTOPERATIVELY WITHOUT FURTHER TRAUMA A MATERIAL FAILURE OF THE DEVICES OCCURRED, SO THAT A NEW OPERATION WAS NECESSARY. INTRAOPERATIVELY, THE SUTURES ALL APPEARED TO BE NO LONGER CONNECTED TO THE TITANIUM ANCHORS, ALTHOUGH THESE HAD NOT BEEN TORN OUT IN THE AREA OF THE TENDON.

  Patient problems: Failure of Implant

  MAUDE report 20418983 ↗
• MalfunctionMay 10, 2024Break; Break

  ON 8/26/2021 IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1928SF-2 SUTURE ANCHOR, CORKSCREW® FT II 5.5 MM X 16.3 MM WITH #2 FIBERWIRE® AND #2 TIGERWIRE® BROKE AT THE BASE OF THE TITANIUM ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. NO PATIENT AFFECTED. ADDITIONAL INFO RECEIVED 9/15/2021 WHILE DOING A RCR THE TITANIUM ANCHOR BROKE AND SUTURE BROKE WHILE KNOTTING THE THREATS TO FIX ANCHOR. SURGEON USED ANOTHER ANCHOR TO TIE PART OF THE ANCHOR THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288536 ↗
• MalfunctionApr 19, 2021Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE AR-1928SF-2 WAS CUT AND COULD NO LONGER BE USED. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1928SF-2.

  Patient problems: Insufficient Information

  MAUDE report 11688572 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS PREVIOUSLY REPORTED BY A PATIENT (CASE (B)(4)) THAT THE PATIENT HAD UNDERGONE A LEFT HAMSTRING TENDON REPAIR PROCEDURE ON (B)(6) 2012. THE PATIENT HAD TORN HIS HAMSTRING OFF THE PELVIC BONE AND THE SURGEON REATTACHED IT USING TWO ARTHREX ANCHORS (AR-1928SNF-2, LOT 433344, CORKSCREW FT II SUTURE ANCHOR AND AR-18928SF-2, LOT 388268), SUTURE ANCHOR, CORKSCREW, FT II). THE PATIENT REPORTED THAT HE HAD BEEN EXPERIENCING PAIN IN PELVIC BONE AND ENTIRE LEG, TENDERNESS AND SWELLING IN ENTIRE HIP AND LEG. THE SYMPTOMS BEGAN A FEW MONTHS AFTER SURGERY WHEN IT WAS NOTICED THE PATIENT STILL HAD SWELLING WHICH HAD NOT DISSIPATED. OVER TIME DISCOMFORT STARTED WITH TINGLING IN THE LEG AND THROUGH THE YEARS THE PAIN AND SWELLING HAD INCREASED WITH CONSTANT DISCOMFORT IN THE HIP BONE. PATIENT HAD BEEN TREATED WITH PHYSICAL THERAPY AND DRUGS. AT TIME OF INITIAL REPORT PATIENT STATED HE MAY HAVE DEVELOPED AN ALLERGY TO THE METAL. MEDWATCH REPORTS (1220246-2019-00942 AND 1220246-2019-00943) WERE SUBMITTED FOR THE POSSIBLE ALLERGIC REACTION. ADDITIONAL INFORMATION OBTAINED 10/15/19: THE PATIENT HAS REPORTED THAT HE UNDERWENT A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT THE TWO ANCHORS (AR-1928SNF-

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Pain; Swelling; Tingling

  MAUDE report 9289953 ↗
• InjuryMar 5, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY A PATIENT, VIA THE ARTHREX WEBSITE, THAT THE PATIENT HAD UNDERGONE A PROCEDURE ON (B)(6) 2012. THE PATIENT HAD TORN HIS HAMSTRING OFF THE PELVIC BONE AND THE SURGEON REATTACHED IT USING TWO ARTHREX ANCHORS, AR-1928SNF-2 (LOT 388266). PATIENT STATES HE MAY HAVE DEVELOPED AN ALLERGY TO THE METAL. PATIENT HAS REQUESTED MATERIAL COMPOSITION OF THE ANCHORS AND HAS ALSO REQUESTED THE TYPE OF HEAD THAT WOULD BE ON THE ANCHOR AND WHAT INSTRUMENT HIS CURRENT ORTHOPEDIC SURGEON WILL NEED TO REMOVE THE ANCHORS. THE REQUESTED INFORMATION WILL BE PROVIDED TO THE PATIENT. THE PART AND LOT NUMBER PROVIDED BY THE PATIENT ARE NOT A VALID MATCH. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT. ADDITIONAL INFORMATION OBTAINED 2/15/19: PER THE SURGERY IMPLANT LOG, THE TWO DEVICES IMPLANTED DURING THE (B)(6) 2012 PROCEDURE WERE: AR-1928SNF-2, LOT 433344, CORKSCREW FT II SUTURE ANCHOR. AR-18928SF-2, LOT 388268, SUTURE ANCHOR,, CORKSCREW, FT II 5.5MM. THE (B)(6) 2012 PROCEDURE WAS A LEFT HAMSTRING TENDON REPAIR. THE PATIENT'S SYMPTOMS INCLUDE PAIN IN PELVIC BONE AND ENTIRE LEG, TENDERNESS AND SWELLING IN ENTIRE HIP AND LEG. THE SYMPTOMS BEGAN A FEW MONTHS AFTER SURGERY WHEN

  Patient problems: Discomfort; Excessive Tear Production; Pain

  MAUDE report 8391556 ↗
• InjuryJan 10, 2019Break

  IT WAS REPORTED THAT DURING A ACHILLES TENDON REFIXATION SURGERY THEY TRIED TO INSERT PART NUMBER AR-1928SNF-2 INTO THE CALCANEUS. DURING INSERTION THE DEVICE BROKE BUT IT WAS DEEP ENOUGH THAT THE PARTIAL ANCHOR COULD BE LEFT INSIDE THE PATIENT. THE BREAKPOINT OF THE ANCHOR WAS LOCATED AT THE THREAD OF THE CONNECTION BETWEEN ANCHOR AND DRIVER. IT WAS NOT POSSIBLE TO REMOVE THE THREAD. THE FRAGMENT WILL REMAIN INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. THE DEVICE WILL NOT BE SENT IN FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8235153 ↗
• InjuryJul 13, 2018Break; Crack

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

  Patient problems: Failure of Implant

  MAUDE report 7685052 ↗
• InjuryDec 14, 2016Patient-Device Incompatibility

  IT WAS REPORTED BY A PATIENT'S MOTHER THAT THE AR-1928SF-2, CORKSCREW FT II SUTURE ANCHOR ((B)(4)), ALONG WITH THE AR-1928SF-3,CORKSCREW FT III SUTURE ANCHOR ((B)(4)), WERE BEING USED IN A LEFT ROTATOR CUFF AND BICEPS TRICEPS REPAIR PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STARTED NOTICING A RED RASH AT THE SURGERY SITE THE DAY AFTER THE PROCEDURE. THE SURGEON RECOMMENDED THE PATIENT GO SEE A DERMATOLOGIST. THE DERMATOLOGIST PRESCRIBED PREDNISONE, AND RECOMMENDED THE PATIENT TO GO TO AN ALLERGIST. PATIENT WAS TESTED FOR H. PYLORI AND CAME BACK NEGATIVE. NO METAL ALLERGY TESTS HAPPENED AT THIS TIME. FINALLY WENT TO THE HOSPITAL AND HAD A HEAVY METAL PANEL DONE FOR ARSENIC, MERCURY, AND LEAD, AND THAT TEST CAME BACK NEGATIVE. TO DATE, PATIENT STILL HAS A RASH AT THE SURGICAL SITE AND ALSO HAS FLUID AND BLOOD COMING FROM HIS EARS. REPORTER HAS BEEN INSTRUCTED THAT SINCE THE PATIENT IS AN ADULT FOR HIPPA PURPOSES ANY FURTHER CONTACT WOULD NEED TO BE DIRECTLY WITH THE PATIENT. ARTHREX HAS REQUESTED THE CONTACT INFORMATION FOR THE PATIENT. AS OF 12/13/2016 THE CONTACT INFORMATION HAS NOT BEEN PROVIDED. PATIENT: MALE, (B)(6).

  Patient problems: Rash; Test Result

  MAUDE report 6173239 ↗
• InjuryDec 14, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT'S MOTHER THAT THE AR-1928SF-2, CORKSCREW FT II SUTURE ANCHOR (CC101313 LINE 176922), ALONG WITH THE AR-1928SF-3,CORKSCREW FT III SUTURE ANCHOR (CC101313 LINE176925), WERE BEING USED IN A LEFT ROTATOR CUFF AND BICEPS TRICEPS REPAIR PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STARTED NOTICING A RED RASH AT THE SURGERY SITE THE DAY AFTER THE PROCEDURE. THE SURGEON RECOMMENDED THE PATIENT GO SEE A DERMATOLOGIST. THE DERMATOLOGIST PRESCRIBED PREDNISONE, AND RECOMMENDED THE PATIENT TO GO TO AN ALLERGIST. PATIENT WAS TESTED FOR H. PYLORI AND CAME BACK NEGATIVE. NO METAL ALLERGY TESTS HAPPENED AT THIS TIME. FINALLY WENT TO THE HOSPITAL AND HAD A HEAVY METAL PANEL DONE FOR ARSENIC, MERCURY, AND LEAD, AND THAT TEST CAME BACK NEGATIVE. TO DATE, PATIENT STILL HAS A RASH AT THE SURGICAL SITE AND ALSO HAS FLUID AND BLOOD COMING FROM HIS EARS. REPORTER HAS BEEN INSTRUCTED THAT SINCE THE PATIENT IS AN ADULT FOR HIPPA PURPOSES ANY FURTHER CONTACT WOULD NEED TO BE DIRECTLY WITH THE PATIENT. ARTHREX HAS REQUESTED THE CONTACT INFORMATION FOR THE PATIENT. AS OF 12/13/16 THE CONTACT INFORMATION HAS NOT BEEN PROVIDED. PATIENT: MALE, AGE (B)(6).

  Patient problems: Erythema; Fluid Discharge; Rash

  MAUDE report 6173234 ↗