Arthrex® AR-13997MFRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867015975), received between Jan 13, 2020 and Sep 11, 2026 — classified as 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Misfire; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736841 ↗
• MalfunctionDec 5, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 11/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06705377 THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPION¿ WAS CUTTING THE SUTURES WHEN BEING USED. THIS OCCURRED DURING USE THEY TRIED SWITCHING OUT NEEDLES TO SEE IF IT WAS A NEEDLE PROBLEM, BUT CONTINUES TO BE AN ISSUE. THE ISSUE IS ISOLATED TO THE SCORPION.

  Patient problems: Insufficient Information

  MAUDE report 20853335 ↗
• MalfunctionAug 26, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 07/30/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPION¿ JAWS WOULD NOT CLOSE. THIS OCCURRED DURING A PROCEDURE SO WAS NOT FUNCTIONING CORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 20063439 ↗
• MalfunctionJun 13, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE DOES NOT PROPERLY TRANSPORT THE THREAD AND CAN'T BE FLUSHED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532841 ↗
• MalfunctionJun 8, 2024Break; Break

  IT WAS REPORTED THAT THE NEEDLE BREAK WHEN THEY ARE USED WITH THE SCORPION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 22-SEP-2022 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT ALL THE NEEDLES WHICH WERE USED WITH THIS SCORPION BROKE. AND THE FAILURE OCCURRED ON (B)(6) 2022. 23-SEP-2022 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SURGERY WHEN THE SURGEON TRIED TO PIERCE THROUGH THE SUPRASPINATUS-TENDON. IT WAS FURTHER REPORTED THAT THE ISSUE HAPPEND WITH AR-13995N WITH THE BATCH 10332413. 27-SEP-2022 UPDATE DW. TWO NEEDLES BROKE DURING A SUPRASPINATUS TEAR ROTATOR CUFF SURGERY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW NEEDLE AND THE SAME SCORPION-MULTIFIRE DEVICE. IT WAS FURTHER REPORTED THAT THE NEEDLES REMAINED CONTAINED INSIDE THE SCORPION AND EVERYTHING COULD BE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494372 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY BICEPS TENDON SYNOSTHESIS SURGERY THE JAW OF THE DEVICE DID NOT CLOSE ANYMORE. THE DEVICE BROKE OUTSIDE OF THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470912 ↗
• MalfunctionJun 4, 2024Break; Break

  ON THE 14TH DECEMBER 2022 IT WAS REPORTED TO ME THAT AN AR-13997MF (MULTIFIRE FASTPASS SCORPION) - (BATCH# UNKNOWN) WAS RECEIVED BACK FROM A CUSTOMER IN AN OLS KIT TAGGED AS BROKEN. NO FURTHER DETAILS ARE KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19459219 ↗
• MalfunctionMay 27, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE DEVICE IS WORN OUT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19401041 ↗
• MalfunctionMay 26, 2024Break; Break

  IT WAS REPORTED THAT THE LOWER COUNTERPART OF THE JAW IS BROKEN OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398916 ↗
• MalfunctionMar 8, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 02/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPION JAW WOULD NOT FULLY CLOSE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869855 ↗
• MalfunctionMar 7, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 2/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13997MF FASTPASS SCORPION-MULTI FIRE JAW WOULD NOT FULLY CLOSE AND, THEREFORE, KEEPS GETTING STUCK ON SOFT TISSUE WHILE BEING USED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856757 ↗
• MalfunctionFeb 16, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 01/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13997MF FASTPASS SCORPION MOUTH IS NOT CLOSING ALL THE WAY. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727670 ↗
• MalfunctionFeb 4, 2024Break; Break

  ON 01/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13997MF SCORPION BROKE DURING SURGERY. ALL FRAGMENTS REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637502 ↗
• MalfunctionJan 16, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 12/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPIONS JAW WOULDN'T CLOSE ALL THE WAY. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519273 ↗
• MalfunctionJan 4, 2024Failure to Discharge; Failure to Discharge

  ON 12/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13999HDN SCORPION NEEDLE IS STUCK. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE SCORPION NEEDLE MISS FIRED MULTIPLE TIMES ON TWO SEPARATE CASES. DIFFERENT SCORPIONS(AR-13997MF) WERE USED IN EACH ROTATOR CUFF REPAIR CASE. CPD WASHED THE SCORPION & NEEDLE AFTER THE FIRST CASE SO WE COULD TROUBLESHOOT THE ISSUE. IT APPEARS THAT AFTER THE SCORPION NEEDLE IS FIRED AND THE RETRACTS BACK IT DOES NOT RETRACT ALL THE WAY. WHAT THIS MEANS IS THE SLOT WHERE THE FIBERWIRE SLIDES INTO THE BOTTOM JAW IS BLOCKED BY THE NEEDLE AND THE FIBERWIRE DOES NOT GET PLACED IN THE NOTCH OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444549 ↗
• MalfunctionJan 4, 2024Failure to Discharge; Failure to Discharge

  ON 12/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06424646 THAT AN AR-13999HDN SCORPION NEEDLE IS STUCK. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE SCORPION NEEDLE MISS FIRED MULTIPLE TIMES ON TWO SEPARATE CASES. DIFFERENT SCORPIONS(AR-13997MF) WERE USED IN EACH ROTATOR CUFF REPAIR CASE. CPD WASHED THE SCORPION & NEEDLE AFTER THE FIRST CASE SO WE COULD TROUBLESHOOT THE ISSUE. IT APPEARS THAT AFTER THE SCORPION NEEDLE IS FIRED AND THE RETRACTS BACK IT DOES NOT RETRACT ALL THE WAY. WHAT THIS MEANS IS THE SLOT WHERE THE FIBERWIRE SLIDES INTO THE BOTTOM JAW IS BLOCKED BY THE NEEDLE AND THE FIBERWIRE DOES NOT GET PLACED IN THE NOTCH OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444006 ↗
• MalfunctionDec 26, 2023Retraction Problem; Retraction Problem

  ON 11/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPION WOULD NOT RETRACT THE NEEDLE. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394101 ↗
• MalfunctionAug 14, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPION HAD AN ISSUE. WHEN USING THE SHOULDER MULTIFIRE FASTPASS SCORPION IN A CASE, THE UPPER JAW, EVEN WHEN CLOSED ALL THE WAY, WAS LIFTING UP. THIS CAUSED THE NEEDLE TO MISS THE JAW AND NOT BE ABLE TO PASS THE SUTURE. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION VIA EMAIL: THIS OCCURRED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE. THE ISSUE WAS FIRST NOTICED IN THE JOINT WHEN PASSING THE FIRST SUTURE OF A SPEED BRIDGE CONSTRUCT. THE NEEDLE WAS MISSING THE SUTURE GATE, AND THE LOCKING MECHANISM SEEMED OFF, SO THEY REMOVED THE SCORPION FROM THE JOINT. THEY TRIED TO LOCK THE JAW DOWN AND FIRE OUTSIDE OF THE JOINT, AND THAT WAS WHEN THEY REALIZED THE JAW WAS LOOSE AND NOT STAYING LOCKED CORRECTLY. THE INSTRUMENT DID NOT BREAK, AND THE NEEDLE WAS OKAY TO USE IN A DIFFERENT SCORPION. THEY OPENED A SEPARATE MULTI-FIRE SCORPION AND USED THE SAME NEEDLE TO COMPLETE THE CASE. THE CASE WAS ONLY IMPACTED WITH A DELAY OF UNDER 15 MINUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541648 ↗
• InjuryMay 9, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13997MF FAST-PASS SCORPION PASSER HAD AN ISSUE DURING A ROTATOR CUFF PROCEDURE. THE TIP OF SCORPION PASSER BROKE OFF INSIDE OF THE PATIENT DURING SUTURE PASSAGE. IT WAS CONFIRMED THE METAL FRAGMENT WAS STUCK IN THE TISSUE. THE SURGEON DEBRIDED THE TISSUE BUT WAS UNABLE TO RECOVER THE METAL FRAGMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16897054 ↗
• InjuryMay 2, 2023Failure to Advance; Failure to Advance

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS, THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPION GETS STUCK IN A FIRE POSITION. THE SURGEON HAD TO OPEN THE SHOULDER. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/10/2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. THE NEEDLE KEPT STICKING IN THE FIRE POSITION. THE SURGEON TRIED MULTIPLE NEEDLES WITHOUT SUCCESS. THE CASE COULD NOT BE COMPLETED ARTHROSCOPICALLY. THE SURGEON HAD TO OPEN THE SHOULDER AND USE FREE NEEDLES. NOTHING BROKE INSIDE THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 4/11/2023: THE SALES REPRESENTATIVE IS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED, BUT THE CASE WAS PROLONGED, DUE TO HAVING TO OPEN THE SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16853576 ↗
• MalfunctionJul 5, 2022Break

  ON 6/21/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-13997MF MULTIFIRE FASTPASS SCORPION HEAD BROKE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022. SURGEON USED A SUTURE LASSO TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 14915117 ↗
• MalfunctionJun 6, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13997MF FASTPASS SCORPION BROKE. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 14604006 ↗
• MalfunctionJan 4, 2022Break

  ON 12/8/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-13997MF SCORPION HAS A BROKEN TIP. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152831 ↗
• MalfunctionNov 22, 2021Break; Difficult to Remove

  ON 11/04/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE BOTTOM JAW OF THE AR-13997MF SCORPION INSTRUMENT, BROKE-OFF. THIS WAS DISCOVERED DURING USE IN A SHOULDER PROCEDURE ON (B)(6) 2021. AFTER SEVERAL ATTEMPTS TO RETRIEVE AND REMOVE THE PIECE IT BECAME EMBEDDED IN THE SURROUNDING SHOULDER CAPSULE. THE CASE WAS COMPLETED USING DEVICE, A SECOND ONE WAS NOT NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12854301 ↗
• MalfunctionNov 15, 2021Break; Entrapment of Device; Device Fell

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-13997MF FASTPASS SCORPION BROKE. THIS OCCURRED DURING A PROCEDURE, AND THE BROKEN FRAGMENT WAS LOST IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 12814364 ↗