Arthrex® AR-13997SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867015982), received between Sep 18, 2017 and Dec 1, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED DURING THE SHOULDER ARTHROSCOPY THAT THE HANDLE OF THE SCORPION INSTRUMENT HAD BROKEN OFF INSIDE THE PATIENT'S BODY. THE BROKEN PIECES 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 ANOTHER PART NUMBER (AR-8925T). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23685767 ↗
• MalfunctionAug 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 08/11/2025, A DISTRIBUTOR REPORTED VIA (B)(6) THAT AR-13997SF SCORPION GOT STUCK AND WOULDN'T CLOSE THE FRONT CLAMP DURING A SHOULDER ARTHROSCOPY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902905 ↗
• MalfunctionFeb 18, 2025Break; Break

  ON 01/22/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13997SF FASTPASS SCORPIONS CLAMP WAS CUTTING THE WIRE INSTEAD OF PUSHING IT. THIS OCCURRED DURING USE, WHERE ANOTHER AR-13997SF FASTPASS SCORPION HAD TO BE OPENED TO FINISH THE SURGERY. ADDITIONAL INFORMATION WAS PROVIDED ON 02/11/2025 VIA (B)(4) WHERE THE ARTHREX SUBSIDIARY EMPLOYEE REPORTED THIS EVENT OCCURRED DURING A ROTATOR CUFF RUPTURE PROCEDURE WHEN THE WIRES WERE PASSED THROUGH THE TENDON. ALL THE FRAGMENTS WERE RECOVERED. THE SUTURE THAT WAS BREAKING WAS AN AR-13997 FIBERTAK ANCHOR SUTURETAPE. THEY USED THE SHOULDER BOX THAT WAS AVAILABLE AT THE HOSPITAL TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403917 ↗
• MalfunctionFeb 7, 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 1/17/2025. 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 21334345 ↗
• MalfunctionNov 6, 2024Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  ON 10/22/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-13997SF FASTPASS SCORPION WONT CLOSE AS ITS LOOSE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616622 ↗
• MalfunctionNov 4, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 10/24/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13997SF FASTPASS SCORPION JAWS DO NOT CLOSE COMPLETELY. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20597380 ↗
• MalfunctionJul 9, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE DEVICE DOESN`T CLOSE PROPERLY AND IT DOESN`T CATCH THE SUTURE. 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 19702343 ↗
• MalfunctionJun 18, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE JAWS DO NOT FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564042 ↗
• MalfunctionJun 17, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 02/02/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-13997SF FASTPASS SCORPION¿ JAW WILL NOT CLOSE. THIS OCCURRED DURING A CASE WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549029 ↗
• MalfunctionMay 26, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398856 ↗
• MalfunctionMay 26, 2024Material Fragmentation; Material Fragmentation

  ON 08/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13991N SUREFIRE SCORPION NEEDLE AND AN AR-13997SF FASTPASS SCORPION HAD AN ISSUE. DURING A PRIMARY SUPRASPINATUS REPAIR PROCEDURE ON (B)(6) 2022, WHEN THE SURGEON WENT TO PASS THE SUTURES AND THE SCORPION NEEDLE THROUGH THE ROTATOR CUFF, WHEN HE WAS GRABBING THE TISSUE, THE NEEDLE WAS AT FIRST NOT PASSING THROUGH THE CUFF. IT FINALLY SHOT THROUGH, AND WHEN IT CAME BACK UP WITH THE SUTURE, THE TIP OF THE NEEDLE WAS GONE. THEY NOTICED THAT THE TIP HAD BROKEN OFF IN THE PATIENT. THEY WERE NOT ABLE TO RETRIEVE THE BROKEN PIECE, IT WAS LEFT INSIDE THE PATIENT. THE SURGEON WAS ALSO NOT SURE IF THE FASTPASS SCORPION HAD MALFUNCTIONED AS WELL AND IN WHAT WAY WAS NOT INDICATED. THEY USED A NEWER AR-13997SF FASTPASS SCORPION (LOT NUMBER UNKNOWN) AND ANOTHER AR-13991N SUREFIRE SCORPION NEEDLE (SAME LOT NUMBER), THIS ONE SHOT THROUGH, THE CASE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS FINE TO DATE. THE SURGEON DEEMED IT SAFE TO LEAVE THE NEEDLE INSIDE AND THAT IT WAS BETTER FOR THE PATIENT THAN RETRIEVING IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19398842 ↗
• MalfunctionApr 30, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE AR-13997SF, WOULD NOT GRASP CORRECTLY. THE CASE WAS COMPLETED BY USING ANOTHER AR-13997SF WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211774 ↗
• MalfunctionApr 25, 2024Pitted; Pitted

  IT WAS REPORTED THAT AR-13997SF HAS PITTING CORROSION. 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 19187756 ↗
• MalfunctionJan 17, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 12/22/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS (B)(4) THAT AN AR-13997SF FASTPASS SCORPION¿ CLAMP DURING THE SURGICAL INTERVENTION, WHEN MOUNTING THE SUTURE IN IT AND CLOSING THE BITE OF THE CLAMP IT IS EVIDENT THAT THE FASTPASS SCORPION CLAMP DOES NOT COMPLETELY CLOSE ITS BITE.

  Patient problems: Insufficient Information

  MAUDE report 18528455 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON DID NOT SUCCEEDED TO USE THE SCORPION DEVICE CORRECTLY AND ANOTHER ONE WAS USED. THE NEXT DAY AFTER SURGERY, FEW FRAGMENTS WERE SEEN ON THE X-RAY INSIDE OF THE JOINT. NO FURTHER INFORMATION RECEIVED. ***UPDATE AVOE (B)(6) 2023 IT WAS FURTHER REPORTED THAT THE SUREFIRE¿ SCORPION¿ NEEDLE AR-13991N (LOT: 15062341) WAS USED WITH THE REPORTED SCORPION DEVICE. IT IS UNCLEAR IF THE FRAGMENTS CAME FROM THE SCORPION OR THE NEEDLE. ***UPDATE AVOE (B)(6) 2023 IT WAS CONFIRMED THAT FOR THE MOMENT NO SECOND SURGERY IS PLANNED TO REMOVE THE FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 18228907 ↗
• MalfunctionOct 25, 2023Break; Break

  ON 10/5/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06050515 THAT AN AR-13997SF FASTPASS SCORPION HAD AN ISSUE. ON (B)(6) 2023, A ROTATOR CUFF PROCEDURE WAS PERFORMED USING THE SCORPION FASTPASS SHOULDER CLAMP AR-13997SF WITH THE NEEDLE AR-13991N, 3 SUTURE PASSES WERE MADE IN THE JOINT AND IT WORKED WELL. IN THE 4TH SUTURE PASS THE CLICK WAS MADE, THIS WAS HEARD LOUDER. WHEN THE CLAMP WAS REMOVED FROM THE JOINT, IT WAS ACTIVATED TO CLOSE IT BUT IT WAS EVIDENCED THAT IT NO LONGER MADE THAT MOVEMENT. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/13/2023, THE ARTHREX SUBSIDIARY EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: NO PART OF THE SCORPION OR THE SCORPION NEEDLE BROKE INSIDE THE PATIENT. THE SCORPION NEEDLE WAS DISCARDED. NO ADDITIONAL SCORPION NEEDLE HAD TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002324 ↗
• MalfunctionMar 27, 2023Break; Break

  ON 03/08/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-13997SF FASTPASS SCORPION BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2023 WHEN THE POINT OF THE SCORPION BROKE OFF. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 16618550 ↗
• MalfunctionDec 13, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-13997SF, FASTPASS SCORPION PIECE IS BROKEN. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. REQUESTED ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984970 ↗
• MalfunctionMay 3, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE AR-13997SF, WOULD NOT GRASP CORRECTLY AS IT WAS LOCKED. THE CASE WAS COMPLETED BY USING ANOTHER AR-13997SF WITHOUT FURTHER ISSUE. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. THE PRECISE CAUSE FOR THE BROKEN MOVING JAW NEAR THE TRAP DOOR PIN COULD NOT BE DETERMINED. THE MATING PART (NEEDLE) OR THE BROKEN JAW WERE NOT RETURNED ALONG WITH THE COMPLAINT DEVICE. CONFIRMED THE FASTPASS JAW HEAT TREAT READING TO BE WITHIN HARDNESS SPECIFICATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. FUNCTION TEST COULD NOT BE PERFORMED DUE TO THE RELATED CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 11761593 ↗
• MalfunctionFeb 9, 2021Break; Crack

  IT WAS REPORTED, THAT THE TIP OF THE AR-13997SF, SCORPION BROKE OFF. THE CALLER DID NOT HAVE ADDITIONAL INFORMATION. ADDITIONAL INFORMATION 1/29/2021: IT WAS REPORTED BY THE SALES REP THAT, THE AR-13997SF, SCORPION BROKE DURING A SHOULDER CASE. THE SURGEON FELT IT CRACK AND IT WAS REMOVED FROM THE SURGERY. THE TIP BROKE OFF IN ONE PIECE AND NOTHING WAS LEFT IN THE PATIENT. THIS DID NOT AFFECT THE SURGERY. ANOTHER SCORPION WAS OPENED AND THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302940 ↗
• MalfunctionNov 4, 2020Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE SURGEON WAS PERFORMING THE SPEED BRIDGE TECHNIQUE ON THE ROTATOR SLEEVE, THE TIP OF THE AR-13997SF, WAS BLOCKED. ADDITIONAL INFORMATION PROVIDED ON 10/21/2020: IT WAS REPORTED THAT THE CLAMP WOULD NO LONGER OPEN AFTER CLAMPING THE ROTATOR CUFF. THE SURGEON WOULD HAVE TO OPEN THE CLAMP SEVERAL TIMES IN ORDER TO GET IT TO UNLOCK. THE SURGEON HAD TO SWITCH FROM A SPEED BRIDGE TECHNIQUE DURING THE SURGERY, TO A DOUBLE ROW TECHNIQUE, IN ORDER TO COMPLETE THE CASE. THE DEVICES USED TO COMPLETED THE CASE ARE AS FOLLOWS: AR-2324; AR-7237; AR-7200.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10785728 ↗
• InjurySep 18, 2017Device Slipped; Component Missing; Failure to Fire

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY CASE, AFTER A FEW PASSES, THE SURGEON WENT TO FIRE THROUGH THE CUFF AND THE FASTPASS SCORPION WOULD NO LONGER FIRE. THE FRONT JAW HAD NO RESISTANCE. A SECOND SCORPION WAS OPENED AND USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT. AFTER COMPLETION OF THE CASE, THE REP OBSERVED THE DEVICE AND STATED THAT IT LOOKED LIKE THE SCORPION LINK WAS MISSING AS THE JAW JUST WOBBLED ON THE END. X-RAYS WERE NOT TAKEN TO CONFIRM IF THE MISSING PIECE WAS NOT LEFT IN THE PATIENT. FOLLOW UP INVESTIGATION: PER THE REP PRESENT FOR THE CASE THE SCORPION TRIGGER SEEMS TO BE THE ISSUE. THE LINK/SPRING IN THE TRIGGER SEEMS TO BE MISSING, MAKING THE JAW WOBBLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872397 ↗