Arthrex® AR-13991NRecalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 00888867015920), received between Jul 8, 2016 and Sep 28, 2026 — classified as 61 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (111 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 25 most recent of 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  On 10-Sept-2026, it was reported by a Sales Representative via SEMS-(b)(6)that an AR-13991N scorpion needle broke off in the rotator cuff. The tip was approximately 1-2mm in width. 2 rounds of x rays and scopes multiple time trying to find in the shoulder. This occurred during use in a case with no patient effect. The fragment remains in the patient. The case was completed with a new scorpion needle with no issues.

  Patient problems: Foreign Body In Patient

  MAUDE report 50914205 ↗
• MalfunctionSep 28, 2026Break

  On 10-Sept-2026, it was reported by a Sales Representative via (b)(4)that an AR-13991N scorpion needle broke off in the rotator cuff. The tip was approximately 1-2mm in width. 2 rounds of x rays and scopes multiple time trying to find in the shoulder. This occurred during use in a case with no patient effect. The fragment remains in the patient. The case was completed with a new scorpion needle with no issues.

  Patient problems: Foreign Body In Patient

  MAUDE report 50913894 ↗
• InjuryMay 26, 2026Fracture

  ON 07-MAY-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-13991N SUREFIRE¿ SCORPION¿ NEEDLE DOES NOT PASS THROUGH. THIS OCCURRED DURING AN ARTHROSCOPIC ACROMIOPLASTY SURGERY OF THE RIGHT SHOULDER THE PHYSICIAN PLACED THE FIRST STITCH, INSPECTED THE TIP OF THE SCORPION NEEDLE, AND CONFIRMED IT WAS INTACT. THE PHYSICIAN THEN SUTURED THE ROTATOR CUFF. THE FIRST STITCH PASSED THROUGH THE TISSUE SMOOTHLY, AND THE NEEDLE REMAINED INTACT. DURING THE ATTEMPT TO PLACE THE SECOND STITCH, THE PHYSICIAN GRASPED VERY THICK TISSUE, AND THE NEEDLE DID NOT PASS THROUGH. THE SURGICAL SUPPORT STAFF REQUESTED THAT THE PHYSICIAN REMOVE THE FORCEPS WITH THE SCORPION NEEDLE TO REPOSITION THE STITCH. THE PHYSICIAN ATTEMPTED TO PASS THE NEEDLE AN ADDITIONAL TWO TIMES. WHEN THE FORCEPS WERE FINALLY REMOVED TO REINSERT THE SUTURE, THE SUPPORT STAFF VERIFIED THE NEEDLE TIP AND FOUND IT FRACTURED. IT WAS DETERMINED THAT THE TIP HAD BROKEN OFF INSIDE THE PATIENT, AND THE PHYSICIAN WAS IMMEDIATELY NOTIFIED. NO REPLACEMENT NEEDLE WAS AVAILABLE TO CONTINUE THE PROCEDURE. AS A RESULT, THE PHYSICIAN MODIFIED THE SURGICAL APPROACH AND CONVERTED THE PROCEDURE TO AN OPEN TECHNIQUE IN ORDER TO SUTUR

  Patient problems: Foreign Body In Patient; Osteopenia/ Osteoporosis

  MAUDE report 25277320 ↗
• MalfunctionMar 26, 2026Break

  ON 18-MAR-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE BROKE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704634 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE NEEDLE BROKE INSIDE THE PATIENT. THE FRAGMENT COULD BE 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 24662105 ↗
• MalfunctionMar 9, 2026Break

  ON 16-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 2 OF AR-13991N SUREFIRE SCORPION NEEDLE TIPS BROKE OFF. IT WAS REPORTED ONE BROKE ON THE BACK TABLE IN THE SCORPION DEVICE AND THE OTHER BROKE IN THE SHOULDER JOINT. THE BROKEN FRAGMENT WAS RETRIEVED WITH AN X-RAY TAKEN TO CONFIRM NO FOREIGN BODY LEFT BEHIND. THIS WAS DISCOVERED DURING A SHOULDER SCOPE/LABRAL REPAIR PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544859 ↗
• MalfunctionFeb 16, 2026Break

  ON 28-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP BROKE DURING SUTURE PASSAGE THROUGH THE ROTATOR CUFF. THIS WAS DISCOVERED DURING A SINGLE-ROW TECHNIQUE PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER NEEDLE. IT WAS FURTHER REPORTED THAT THEY BELIEVE THE SURGEON MAY HAVE ENCOUNTERED SOME RESISTANCE DURING THE PASSAGE AND ENDED UP APPLYING FORCE, WHICH CAUSED THE BREAKAGE. THE BONE QUALITY WAS REPORTED AS CANCELLOUS BONE AND NO FRAGMENT REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344353 ↗
• MalfunctionFeb 5, 2026Break

  ON 15-JAN-2026, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-13991N SCORPION NEEDLE TIP FELL OFF AND INTO THE PATIENT AND THE PIECE THAT FELL INTO THE PATIENT REMAINS INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 27-JAN-2026: IT WAS FURTHER REPORTED THAT THIS OCCURRED DURING A LEFT SHOULDER ARTHROSCOPY, LEFT ROTATOR CUFF REPAIR PROCEDURE WITH A 15-MINUTE DELAY AND AN ADDITIONAL 15MM OF ANESTHESIA ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24270012 ↗
• MalfunctionFeb 5, 2026Break

  ON 15-JAN-2026, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-13991N SCORPION NEEDLE TIP FELL OFF AND INTO THE PATIENT AND THE PIECE THAT FELL INTO THE PATIENT REMAINS INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 27-JAN-2026: IT WAS FURTHER REPORTED THAT THIS OCCURRED DURING A LEFT SHOULDER ARTHROSCOPY, LEFT ROTATOR CUFF REPAIR PROCEDURE WITH A 15-MINUTE DELAY AND AN ADDITIONAL 15MM OF ANESTHESIA ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24269939 ↗
• MalfunctionJan 8, 2026Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP BROKE DURING THE PASSAGE OF THE SUTURE. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE WITH NO PATIENT HARM. THE SURGERY WAS COMPLETED USING A 90° SUTURELASSO. NO FRAGMENT REMAINED IN THE PATIENT, AND THE BONE QUALITY WAS NOT VERY GOOD. THERE WAS A 30-MINUTE DELAY IN THE PROCEDURE, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001961 ↗
• MalfunctionDec 31, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 09-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP WAS BENT. IT WAS REPORTED THAT THE SCORPION FAILED TO PASS THE SUTURE, SEVERAL ATTEMPTS WERE MADE, THEN THE SCORPION NEEDLE WAS CHECKED, AND IT WAS FOUND THAT THE TIP WHERE THE NOTCH IS LOCATED WAS BENT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933108 ↗
• MalfunctionDec 18, 2025Break; Break

  ON 11/27/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP BROKE ON THE FOURTH SUTURE PASS DURING A ROTATOR CUFF REPAIR PROCEDURE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839147 ↗
• MalfunctionDec 17, 2025Break; Break

  ON 11/27/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP BROKE DURING A SUTURE PASSAGE, AND ANOTHER SUTURE PASSER WAS USED. THE NEEDLE TIP REMAINED INSIDE THE JOINT, CAUSING A 30-MINUTE DELAY IN THE ROTATOR CUFF REPAIR PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 12/05/25. THE REP ADVISED THAT IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO PASS THE NEEDLE THROUGH THE CUFF TO PLACE THE STITCH, WITH NO OTHER DEVICE INVOLVED AT THE TIME. THEY ATTEMPTED TO REMOVE THE FRAGMENT OF THE BROKEN NEEDLE BUT WERE UNSUCCESSFUL. THE EXACT ADDITIONAL TIME COULD NOT BE QUANTIFIED; HOWEVER, IT WAS REPORTED THAT THE SURGEON SPENT SOME TIME TRYING TO REMOVE THE FRAGMENT AND EVENTUALLY GAVE UP.

  Patient problems: Foreign Body In Patient

  MAUDE report 23830109 ↗
• MalfunctionDec 16, 2025Break; Break

  ON 11/25/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE BROKE INSIDE THE CAVITY DURING THE TENDON SUTURING. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE WITH NO PATIENT HARM OR DELAY REPORTED. ADDITIONAL INFORMATION WAS PROVIDED ON 12/04/2025: IT WAS FURTHER REPORTED THAT THE FRAGMENT WAS NOT LOCATED AND IT CANNOT BE CONFIRMED WHETHER ANY PART REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815666 ↗
• MalfunctionDec 10, 2025Break; Break

  ON 11/24/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE BROKE. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR SURGERY WITH NO PATIENT HARM. IT WAS REPORTED THAT SCORPION FORCEPS WERE USED AND THE NEEDLE BROKE WHEN THE POINT WAS PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771296 ↗
• MalfunctionDec 9, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11/17/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE WAS BENT ON THE FIRST SHOT WITHOUT ALLOWING THE SUTURE TO PASS THROUGH. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759828 ↗
• MalfunctionOct 28, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-13991N, SUREFIRE¿ SCORPION¿ NEEDLE, THE SCORPION NEEDLE TIP BROKE WHEN PASSING SUTURES THROUGH THE GRAFT OUTSIDE OF THE JOINT. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WHERE A TROCAR NEEDLE WAS USED TO PASS THE SUTURES THROUGH THE AFLEX GRAFT INSTEAD. ADDITIONAL INFORMATION RECEIVED ON 13TH OCT 2025: THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405197 ↗
• MalfunctionSep 18, 2025Break; Break

  ON 08/27/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE BROKE DURING SURGERY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084187 ↗
• MalfunctionSep 9, 2025Break; Break

  ON 08/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SCORPION NEEDLE WHEN PASSING THE NEEDLE THROUGH THE FORCEPS, IT DOES NOT TAKE SUTURES AND ENDS UP BREAKING THE TIP OF THE NEEDLE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999796 ↗
• MalfunctionAug 8, 2025Break; Break

  ON 07/21/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE¿ SCORPION¿ NEEDLE BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22748801 ↗
• MalfunctionJun 30, 2025Break; Break

  ON 06/05/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE¿ SCORPION¿ NEEDLE BROKE. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22357234 ↗
• MalfunctionMay 23, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-06867825 THAT AN AR-13991N SUREFIRE SCORPION NEEDLE MATERIAL BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080430 ↗
• MalfunctionMay 8, 2025Break; Break

  ON 04/23/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE¿ SCORPION¿ NEEDLE BROKE OFF AT THE END OF THE LAST THREAD. THE SCORPION WORKED NORMALLY DURING THE PASSAGE OF ALL THE THREADS, IT ONLY BROKE ON THE LAST ONE, THEY USED THE BIRD AND FINISHED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21985789 ↗
• MalfunctionMar 20, 2025Break; Break

  ON 03/04/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-13991N SUREFIRE¿ SCORPION¿ NEEDLE TIP FRACTURED. THIS OCCURRED DURING A MINI-OPEN ROTATOR CUFF REPAIR SURGERY WHEN THE TIP OF THE SCORPION¿ NEEDLE FRACTURED, AND THE SURGICAL TEAM WAS UNABLE TO DETERMINE WHETHER THE FRAGMENT REMAINED INSIDE THE PATIENT OR WAS EXPELLED EXTERNALLY. THE FACILITY CONDUCTED AN INITIAL RADIOGRAPHIC ASSESSMENT USING STANDARD X-RAY IMAGING, WHICH DID NOT REVEAL ANY METALLIC FRAGMENTS IN THE PATIENT'S SHOULDER. HOWEVER, THE TEAM PROCEEDED WITH A FLAT PLATE X-RAY, FOR WHICH RESULTS WERE STILL PENDING AT THE TIME OF THIS REPORT. THERE WAS AN EXTENDED ANESTHESIA DURATION DUE TO THE ADDITIONAL INTRAOPERATIVE ASSESSMENT PERFORMED TO EVALUATE THE POTENTIAL PRESENCE OF A RETAINED FRAGMENT. THE CUSTOMER DID NOT REPORT ANY FURTHER PATIENT COMPLICATIONS, ADVERSE REACTIONS, OR PROCEDURAL DEVIATIONS ASIDE FROM THE INCREASED OPERATIVE TIME. THERE WERE NO ADDITIONAL MEDICAL INTERVENTIONS WERE DEEMED NECESSARY BY THE SURGICAL TEAM AT THIS TIME.

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

  MAUDE report 21652082 ↗
• MalfunctionFeb 6, 2025Break; Break

  ON 1//13/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-13991N SUREFIRE SCORPION NEEDLE BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED ON 1/23/2025: THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY WITH AN RCR PROCEDURE ON (B)(6)2025. THE NEEDLE BROKE INTO FRAGMENTS INSIDE THE PATIENT'S SHOULDER, AND UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENTS. THE AR-13991N SUREFIRE SCORPION NEEDLE WAS USED WITH AN AR-13997SF WHEN IT BROKE. THE FASTPASS SCORPION DID NOT MALFUNCTION OR EXPERIENCE DAMAGE. THE CASE WAS DELAYED THIRTY MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 21320546 ↗