Arthrex® AR-1915SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867022652), received between Nov 14, 2017 and Sep 9, 2025 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1915SF SUTURE ANCHORS SUTURES BROKE FROM THE ANCHOR AFTER BEING INSERTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005892 ↗
• MalfunctionAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1915SF SUTURE ANCHOR DISLODGED UPON IMPACTION DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22922068 ↗
• MalfunctionAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/28/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1915SF SUTURE ANCHOR BROKE. THIS OCCURRED DURING A CASE WHEN THE ANCHOR WAS PLACED THE IMPLANT BROKE COMPLETELY AND CAME OUT WITH THE SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793431 ↗
• InjuryJul 3, 2025Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED ON 6/26/2025: AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE PATIENT FELL OFF A BICYCLE AND SUSTAINED A LEFT POSTEROLATERAL ELBOW DISLOCATION ALONG WITH ADDITIONAL INJURIES. IN 2024, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A CLOSED, DISPLACED FRACTURE OF THE RADIAL HEAD/NECK. PROCEDURES ALSO INCLUDED PRIMARY REPAIR OF THE LATERAL ULNAR COLLATERAL LIGAMENT USING LOCAL TISSUE AND OPEN TREATMENT OF THE ELBOW DISLOCATION. DURING SURGERY, A RADIAL HEAD FRACTURE FRAGMENT WAS EXCISED, AND THE REMAINING RADIAL HEAD WAS ANATOMICALLY REDUCED AND STABILIZED USING A 2.4MM LOCKING COMPRESSION PLATE. THE LATERAL ULNAR COLLATERAL LIGAMENT WAS REPAIRED UTILIZING A METAL ANCHOR AND FIBERWIRE. A CT SCAN PERFORMED IN 2025 REVEALED PROGRESSIVE DISPLACEMENT OF VOLAR FRAGMENTS THAT WERE NOT INCLUDED IN THE INITIAL FIXATION. ADDITIONAL CONCERNS WERE RAISED REGARDING POTENTIAL LOOSENING OR INFECTION AT THE LATERAL EPICONDYLE ANCHOR SITE, ALONG WITH THE PRESENCE OF SMALL BONY FRAGMENTS IN THE POSTEROLATERAL ASPECT OF THE ELBOW.

  Patient problems: Failure of Implant

  MAUDE report 22398883 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE SURGERY, AFTER THE ANCHOR WAS INSERTED, IT WAS FOUND THAT THE EYLET OF THE ANCHOR WAS DEFECTIVE AND THEREFORE THE FIBERWIRE BECAME DETACHED FROM THE ANCHOR. IT WAS FURTHER REPORTED THAT THE ANCHOR 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 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 21909743 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A HAMSTRING SURGERY THE TIP OF THE CORKSCREW BROKE WHEN INSERTING THE DEVICE. ALL FRAGMENTS WERE REMOVED 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 21646312 ↗
• MalfunctionNov 27, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  ADDITIONAL INFORMATION PROVIDED ON 11/28/2024 BY SUBSIDIARY EMPLOYEE WHO STATED THAT THE PROCEDURE BEING PERFORMED WAS A LATERAL ANKLE INSTABILITY AND THE INSTRUMENT USED TO PREPARE THE BONE SOCKET FOR INSERTION WAS A SUTURE TAK ANKLE GUIDE AND DRILL. THE PATIENT'S BONE WAS POROUS. THEY USED A SWIVELOCK 4.75 AR-2324BCC-2 ANCHOR TO COMPLETE THE CASE. NO EVIDENCE WAS TAKEN AND THE ANCHOR WAS DISPOSED OF IN ACCORDANCE WITH HOSPITAL PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790915 ↗
• MalfunctionMay 28, 2024Break; Break

  ON 04/29/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1915SF CORKSCREW ANCHOR BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED BY USING ANOTHER AR-1915SF CORKSCREW ANCHOR. THERE WAS A FIVE-MINUTE DELAY WITHOUT ADDITIONAL ANESTHESIA. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE REDUCTION INTERNAL FIXATION AND TRIANGULAR LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403972 ↗
• MalfunctionMay 9, 2024Break; Break

  ON 05/16/2024 ADDITIONAL INFORMATION WAS RECEIVED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL WHO STATED THAT THE PROCEDURE PERFORMED WAS A MEDIAL MALLEOLUS FRACTURE. PHOTOS WERE TAKEN AND ARE ATTACHED. THE PATIENT'S BONE QUALITY WAS RIGID. A 2.4MM DRILL TIP GUIDE WIRE WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19279757 ↗
• MalfunctionMar 13, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 2/23/2023: THIS WAS DISCOVERED DURING AN ANKLE PROCEDURE AND COMPLETED USING ANOTHER ANCHOR BUT THE PART NUMBER IS UNKNOWN. ALL BROKEN FRAGMENTS WERE RETRIEVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16528471 ↗
• MalfunctionNov 16, 2022Break

  ON 10/27/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1915SF CORKSCREW SUTURE ANCHOR TIP BROKE OFF DURING INSERTION. HALF OF THE CORKSCREW WAS LEFT IN THE PATIENT AND THE REST WAS RETRIEVED. THIS WAS DISCOVERED DURING A HIP FRACTURE DISLOCATION AND LABRUM DETACHMENT PROCEDURE ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 15803938 ↗
• MalfunctionJun 6, 2022Break

  ON 5/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1915SF CORKSCREW SUTURE ANCHOR BROKE OFF THE INSERTER DURING INSERTION. SURGEON WAS USING A TOTAL OF THREE CORKSCREW SUTURE ANCHORS FOR THE PROCEDURE, THE FIRST AND THIRD WERE INSERTED WITHOUT ANY ISSUES. THIS WAS DISCOVERED DURING A DISTAL BICEP REPAIR ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14601552 ↗
• MalfunctionFeb 14, 2022Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE SURGERY THE TIP OF THE IMPLANT BROKE OFF WHILE THE SURGEON INSERTED IT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13526388 ↗
• MalfunctionApr 8, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR PROCEDURE, WHEN THE SURGEON WAS TENSIONING, THE AR-1915SF BROKE. THE SUTURE WAS REMOVED AND A NEW AR-1915SF WAS USED TO COMPLETE THE CASE.

  Patient problems: Failure of Implant

  MAUDE report 11633374 ↗
• MalfunctionApr 1, 2021Fracture

  IT WAS REPORTED THAT THE SURGEON TURNED THE ANCHOR ON THE AR-1915SF AND THE ANCHOR FRACTURED. THE SURGERY WAS COMPLETED USING ANOTHER NEW PRODUCT WITH THE SAME PRODUCT CODE AND LOT NUMBER. THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL, AND A PHOTO OF THE PRODUCT COULD NOT BE PROVIDED AS THE HOSPITAL DID NOT TAKE ANY PHOTO OF THE PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 11602321 ↗
• InjurySep 4, 2018Break; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANKLE LIGAMENTOPLASTY SURGERY THE ANCHOR BROKE DURING THE INTRODUCTION INTO THE LATERAL MALLEOLAR TIP. THE LOCATION WAS WELL PREPARED PRIOR TO IMPLEMENTATION, WITH A PIN. IT WAS IMPOSSIBLE TO EXTRACT THE ANCHOR, AND DIFFICULT TO PUT THE SECOND ONE, BECAUSE OF THE ANCHOR THAT REMAINED IN PLACE. THE SURGERY WAS LENGTHENED BY 45 MINUTES. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN FRAGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER.

  Patient problems: No Information

  MAUDE report 7841974 ↗
• InjuryJul 13, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ANCHOR HAS BROKEN OFF AT THE INLET OF THE INSERTION SLEEVE. ADDITIONAL INFORMATION OBTAINED: A THREAD ANCHOR WAS PREDRILLED WITH A DRILL. SUBSEQUENTLY, WHEN THE ANCHOR WAS SCREWED IN, THE ANCHOR AT THE EYELET BROKE OFF. THE THREAD HAS BEEN LEFT AS THERE IS NO PROJECTION. PERFORMED SURGERY WAS AN REFIXATION BICEP TENDON.

  Patient problems: No Information

  MAUDE report 7686238 ↗
• InjuryNov 14, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT MIDWAY THROUGH A TOTAL KNEE ARTHROPLASTY CASE, THE TIP OF THE CORKSCREW SUTURE ANCHOR BROKE-OFF INTO THE PATIENT'S KNEE. PER REPORTER, THE SURGEON STATED THAT IT WOULD CAUSE MORE DAMAGE TO TRY AND RETRIEVE THE TIP RATHER THAN JUST LEAVING IT IN. THE TIP OF THE ANCHOR WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH NO FURTHER INCIDENT. PATIENT IS A FEMALE, AGE (B)(6), WEIGHING (B)(6). FOLLOW-UP INVESTIGATION: DATE OF SURGERY WAS (B)(6) 2017. DEVICE PORTION THAT DID NOT REMAIN IN PATIENT HAS BEEN RETURNED FOR EVALUATION. PATIENT SURGERY WAS AN OPEN PROCEDURE AND NO ADDITIONAL INCISIONS WERE MADE. A CORKSCREW ANCHOR WAS BEING USED DURING THE TOTAL KNEE ARTHROPLASTY CASE BECAUSE THE PATELLA TENDON WAS SEVERED AND NEEDED TO BE REPAIRED. THE SURGEON ATTEMPTED TO REPAIR THE PATELLA TENDON WITH THE SUTURE ANCHOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 7027717 ↗