Arthrex® AR-13995NRecalls & reported problems

Summary

The FDA's MAUDE database contains 430 adverse event reports that list this exact device (DI 00888867015951), received between Jul 12, 2016 and Sep 29, 2026 — classified as 192 injuries, 238 malfunctions.

The most frequently reported specific device problem is “Break” (397 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 430 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50933888 ↗
• MalfunctionApr 10, 2026Break

  ON 24TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-13995N, MULTIFIRE¿ SCORPION¿ NEEDLE, APPROXIMATELY 2MM OF THE TIP WAS MISSING. THIS WAS DETECTED DURING AN ARTHROSCOPIC ROTATOR CUFF SUTURE SURGERY ON (B)(6) 2026. THE SURGEON SEARCHED AROUND THE SURGICAL FIELD AND ATTEMPTED TO FIND AND REMOVE IT UNDER THE ARTHROSCOPY BUT FAILED. USING THE C-ARM FLUOROSCOPY, IT WAS FOUND THAT THERE WAS ABOUT 1MM * 22MM FOREIGN OBJECT. IT WAS CONSIDERED TO BE CAUSED BY THE THICKNESS OF THE TENDON DURING THE TENDON SUTURE PROCESS AND THEY SUSPECTED THAT IT WAS DUE TO THE WEAKNESS POINT OF THE INNER CORE BREAKING. THROUGH X-RAY FLUOROSCOPY, IT WAS DETERMINED THAT THE FOREIGN OBJECT REMAINED UNDER THE ACROMION. THE ARTHROSCOPY FULLY EXPLORED THE UPPER AND LOWER SURFACES OF THE TENDON BUT COULD NOT FIND THE BROKEN PART OF THE INNER CORE. COMBINED WITH REPEATED FLUOROSCOPIC EXAMINATIONS DURING THE OPERATION, IT WAS CONSIDERED THAT THE FOREIGN OBJECT WAS INSIDE THE TENDON AND STABLE. AFTER DISCUSSION AMONG THE DOCTORS OF THE SURGICAL TEAM, FORCIBLY REMOVING THE FOREIGN OBJECT WOULD CAUSE SIGNIFICANT DAMAGE TO THE TENDON, HENCE THE DECISION FOR REMOVAL WAS ABAND

  Patient problems: Foreign Body In Patient

  MAUDE report 24844413 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING THE SHOULDER SURGERY, THE TIP OF THE NEEDLE BROKE OFF AND REMAINED IN THE PATIENT´S SHOULDER. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 19-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE TIP OF THE NEEDLE BROKE OFF AND REMAINED IN THE PATIENT´S SHOULDER. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24834012 ↗
• MalfunctionMar 23, 2026Break

  ON 4TH MAR 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-13995N CORPION-MULTIFIRE NEEDLE BROKE AFTER THE SUTURE WAS PASSED THROUGH. IN ADDITION, THE BIO-COMP SWVLK C, CLD 4.75X19.1MM BATCH 15412798, WAS OBSERVED TO HAVE SWIVELOCK ANCHOR PULLED OUT. THIS WAS DETECTED DURING THE PROCEDURE ON (B)(6) 2026 AND WAS POSSIBLY DUE TO THE PATIENT HAVING SOFT BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661373 ↗
• MalfunctionFeb 23, 2026Break

  ON 05-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-13995N SCORPION-MULTIFIRE NEEDLE BROKE. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415550 ↗
• MalfunctionFeb 18, 2026Break

  ON 30-JAN-2026, IT WAS REPORTED BY A COMPETENT AUTHORITY VIA EMAIL THAT THE TIP OF AN AR-13995N MULTIFIRE SCORPION NEEDLE BROKE OFF INTRAOPERATIVELY AND REMAINED WITHIN THE SURGICAL SITE. THE FRAGMENT WAS IDENTIFIED BY THE RN UPON REMOVAL OF THE INSTRUMENT. THE SURGEON DETERMINED THAT RETRIEVAL OF THE RETAINED FRAGMENT WAS NOT NECESSARY. THE EVENT OCCURRED DURING A SHOULDER ARTHROSCOPY PROCEDURE PERFORMED ON (B)(6) 2026 WITH NO PATIENT HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24378573 ↗
• MalfunctionFeb 2, 2026Break

  ON 12TH JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-13995N, MULTIFIRE¿ SCORPION¿ NEEDLE, IT BROKE DURING A SURGERY. THE NURSE USED THE C-ARM X-RAY MACHINE FOR IMAGING AND INSPECTION WHERE THE SURGEON REPEATEDLY EXPLORED. HOWEVER, THE SURGEON FAILED TO LOCATE THE BROKEN PART, AND IT WAS INFORMED THAT IT WAS LOST. THIS WAS DETECTED DURING A PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 24235369 ↗
• MalfunctionOct 24, 2025Break; Break

  ON 10/16/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, AN AR-13995N MULTIFIRE SCORPION NEEDLE BROKE, CAUSING METAL FRAGMENTS TO REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23379040 ↗
• MalfunctionOct 22, 2025Break; Break

  ON 10/16/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, AN AR-13995N MULTIFIRE SCORPION NEEDLE BROKE, CAUSING METAL FRAGMENTS TO REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23358311 ↗
• MalfunctionOct 22, 2025Break; Break

  ON 10/16/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, AN AR-13995N MULTIFIRE SCORPION NEEDLE BROKE, CAUSING METAL FRAGMENTS TO REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23358231 ↗
• MalfunctionOct 22, 2025Break; Break

  ON 10/16/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, AN AR-13995N MULTIFIRE SCORPION NEEDLE BROKE, CAUSING METAL FRAGMENTS TO REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23358140 ↗
• MalfunctionOct 22, 2025Break; Break

  ON 10/16/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY ON (B)(6) 2025, AN AR-13995N MULTIFIRE SCORPION NEEDLE BROKE, CAUSING METAL FRAGMENTS TO REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23357035 ↗
• MalfunctionOct 21, 2025Break; Break

  ON 10/16/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY ON (B)(6) 2025, AN AR-13995N MULTIFIRE SCORPION NEEDLE BROKE, CAUSING METAL FRAGMENTS TO REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23352632 ↗
• MalfunctionOct 21, 2025Break; Break

  ON 10/06/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-13995N SCORPION MULTIFIRE NEEDLE BROKE ON THE PASS THROUGH DURING A DURING A CASE WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10/10/25 ADVISED THAT THE NEEDLE BROKE WHILE PASSING A SUTURE THROUGH RCR DURING A SHOULDER SCOPE WITHOUT HARMING THE PATIENT. NO ATTACHMENT WAS USED WITH THE NEEDLE. ALL PIECES WERE RETRIEVED FROM THE PATIENT, WHICH CAUSED A TWO-MINUTE DELAY, AND THE SCOPE WAS COMPLETED USING AN HD SCORPION NEEDLE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349693 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE TIP BROKE. ALL PARTS WERE RETRIEVED. 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 22950925 ↗
• MalfunctionAug 6, 2025Break; Break

  ON 17TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-13995N, MULTIFIRE¿ SCORPION¿ NEEDLE, THE NEEDLE BROKE, AND SOME METALLIC FRAGMENTS WERE FOUND LEFT INSIDE THE SUBSCAPULARIS TENDON. CONSIDERING NEGATIVE INFLUENCE IF RETRIEVE THE FRAGMENTS, THE SURGEON DECIDED TO KEEP THE FRAGMENTS INSIDE THE BODY AFTER COMMUNICATING WITH THE PATIENT. BUT THERE COULD BE RISK FROM SURGEON'S POINT OF VIEW. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS STILL COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22726245 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE NEEDLE BROKE. ALL FRAGMENTS WERE 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 22676500 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE NEEDLE BROKE OFF AT THE TIP. THE BROKEN PART WAS LEFT INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22557999 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE NEEDLE BROKE OFF INSIDE THE BONE. NO FURTHER INFORMATION WAS PROVIDED. UPDATE AVOE 30-JUN-2025 IT WAS FURTHER REPORTED THAT THE ERROR OCCURRED DURING A SHOULDER CUFF REPAIR SURGERY. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494232 ↗
• MalfunctionJul 8, 2025Break; Break

  ON 06/11/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-13995N SCORPION MULTIFIRE NEEDLE TIP BROKE OFF. THE BROKEN PIECE DID NOT GO INTO THE PATIENT. THIS WAS DISCOVERED A ROTATOR CUFF REPAIR AND THE CASE WAS FINISHED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438173 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WHERE THE DEVICE WAS BEING USED, THE SURGEON NOTICED THE TIP OF THE NEEDLE WAS MISSING. THE SURGEON LOOKED AROUND THE SURGICAL WOUND AND COULD NOT FIND THE TIP. IT WAS FURTHER REPORTED THAT WASHING AND SUCTION WAS BEING USED AT THE TIME, AND THEREFORE THE SURGEON IS UNSURE IF THE FRAGMENT WAS WASHED OUT OR NOT. NO FURTHER INFORMATION RECEIVED

  Patient problems: Insufficient Information

  MAUDE report 22298920 ↗
• MalfunctionJun 20, 2025Break; Break

  ON 28TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-13995N MULTIFIRE¿ SCORPION¿ NEEDLE, THE SCORPION NEEDLE TIP BROKE. THIS WAS DETECTED DURING USE IN AN OPEN ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY AS A NEW NEEDLE WAS OPENED. 29 MAY 2025 - THE COMPLAINT INITIATOR UPDATED THAT THE NEEDLE WAS BEING FIRED BY AR-13999MF. WHILST THE ARTHREX EMPLOYEE WAS IN THEATRE THE SCORPION NEEDLE TIP WAS NOT RETRIEVED (COULD NOT BE FOUND) HOWEVER THE SURGEON CONFIRMED THAT IT WAS NOT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22296921 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY IT WAS NOTICED THAT WHEN THE SURGEON HANDED THE DEVICE BACK THE TIP WAS MISSING. THE BROKEN PART IS PRESUMABLY STILL IN THE SHOULDER JOINT AND TO SMALL TO FIND. TRIANGULAR IN SHAPE APPROXIMATELY 3MM IN LENGTH AT ITS LONGEST. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22201629 ↗
• MalfunctionMay 22, 2025Break; Break

  ON 7TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-13995N MULTIFIRE¿ SCORPION¿ NEEDLE, THE NEEDLES BROKE IN THE CUFF WHILST TRYING TO PASS FIBERTAPE. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY AS A NEW NEEDLE WAS OPENED, HOWEVER TWO BROKE IN THE PATIENT. ON 8TH MAY 2025 - IT WAS UPDATED BY THE COMPLAINT INITIATOR THAT THEIR PROCEDURAL DELAY 15MIN AS INDICATED BY COMPLAINT INITIATOR AS THERE WAS METAL IN THE CUFF. THE BROKEN FRAGMENTS WERE NOT RETRIEVED AS THEY WERE BURIED IN THE PATIENT'S TISSUE AND TO REMOVE THEM WOULD BE MORE HARMFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22074758 ↗
• MalfunctionMay 22, 2025Break; Break

  ON 7TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-13995N MULTIFIRE¿ SCORPION¿ NEEDLE, THE NEEDLES BROKE IN THE CUFF WHILST TRYING TO PASS FIBERTAPE. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY AS A NEW NEEDLE WAS OPENED, HOWEVER TWO BROKE IN THE PATIENT. ON (B)(6) 2025 - IT WAS UPDATED BY THE COMPLAINT INITIATOR THAT THERE PROCEDURAL DELAY>15MIN AS INDICATED BY COMPLAINT INITIATOR AS THERE WAS METAL IN THE CUFF. THE BROKEN FRAGMENTS WERE NOT RETRIEVED AS THEY WERE BURIED IN THE PATIENT'S TISSUE AND TO REMOVE THEM WOULD BE MORE HARMFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22074593 ↗