Arthrex® AR-13999HDNRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00888867374003), received between Oct 25, 2023 and Sep 1, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break

  On (b)(6) 2026, an FDA MedSun notification was received via email. A facility representative reported that an AR-13999HDN HD Scorpion Needle with Mega Loader had the tip of the needle break off and remain in the patient during the intraoperative phase. The surgeon confirmed that a 2.5 mm metal tip was retained in the rotator cuff. The surgeon stated that attempts to identify the retained tip were unsuccessful and that further disruption of the rotator cuff to locate the tip was not pursued because it would cause harm. The surgeon explained the finding to the patient and documented the discussion. The surgeon also discussed the finding with the radiologist, and it was determined that manipulation of the rotator cuff should be discontinued and that retention of the tip would not affect the clinical outcome. This was discovered during a left shoulder arthroscopy procedure in (b)(6) 2026.

  Patient problems: Foreign Body In Patient

  MAUDE report 50545940 ↗
• MalfunctionSep 1, 2026Break

  On (b)(6) 2026, an FDA MedSun notification was received via email. A facility representative reported that an AR-13999HDN HD Scorpion Needle with MegaLoader had the tip of the needle break off and remain in the patient during the intraoperative phase. The surgeon confirmed that a 2.5 mm metal tip was retained in the rotator cuff. The surgeon stated that attempts to identify the retained tip were unsuccessful and that further disruption of the rotator cuff to locate the tip was not pursued because it would cause harm. The surgeon explained the finding to the patient and documented the discussion. The surgeon also discussed the finding with the radiologist, and it was determined that manipulation of the rotator cuff should be discontinued and that retention of the tip would not affect the clinical outcome. This was discovered during a left shoulder arthroscopy procedure in (b)(6) 2026.

  Patient problems: Foreign Body In Patient

  MAUDE report 50545524 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50432506 ↗
• MalfunctionJan 2, 2026Material Twisted/Bent

  ON 12-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13999HDN SCORPION NEEDLE WAS BENT WHILE ATTEMPTING TO DEPLOY THE SUTURE. THIS OCCURRED DURING USE IN A ROTATOR CUFF REPAIR CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944879 ↗
• MalfunctionJan 2, 2026Material Twisted/Bent

  ON 12-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13999HDN SCORPION NEEDLE WAS BENT WHILE ATTEMPTING TO DEPLOY THE SUTURE. THIS OCCURRED DURING USE IN A ROTATOR CUFF REPAIR CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944790 ↗
• MalfunctionJan 2, 2026Material Twisted/Bent

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13999HDN SCORPION NEEDLE WAS BENT WHILE ATTEMPTING TO DEPLOY THE SUTURE. THIS OCCURRED DURING USE IN A ROTATOR CUFF REPAIR CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944638 ↗
• MalfunctionJul 31, 2025Device Damaged by Another Device; Firing Problem; Device Damaged by Another Device; Firing Problem

  ON 5TH JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-13999MF, FASTPASS SCORPION, SL-MF, OR NEEDLE KEPT CUTTING THE SUTURE WHEN IT WAS FIRED THROUGH CUFF TISSUE. THIS HAD HAPPENED PREVIOUSLY WITH THE SAME SCORPION INSTRUMENT AND A DIFFERENT NEEDLE SO THE ARTHREX EMPLOYEE QUERIES WHETHER THE TRAP DOOR IS OK AND IF SOMETHING NEEDS TO BE REPAIRED. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER SCORPION HANDPIECE INSTRUMENT WAS OPENED.

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

  MAUDE report 22674513 ↗
• MalfunctionJul 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 06/20/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-13999HDN HD SCORPION¿ NEEDLE WITH MEGALOADER GOT STUCK WHEN PASSING THROUGH THE CUFF AND WOULDN'T COME BACK DOWN THE TRAP DOOR. NO PATIENTS WERE HARMED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529707 ↗
• MalfunctionApr 23, 2025Break; Break

  ON 4/11/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-13999HDN HD SCORPION NEEDLE TIP BROKE OFF INTRAOPERATIVELY, DURING SUTURING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 4/14/2025.

  Patient problems: Insufficient Information

  MAUDE report 21892522 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE TIP OF THE SCORPION NEEDLE BROKE. A PIECE OF THE NEEDLE IS STILL IN THE PATIENT SUPRASPINATUS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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. ON 17-FEB-2025: REVEIVED FURTHER INFORMATION THAT THETIP OF THE SCORPION NEEDLE BROKE AND IS STILL IN THE SUPRA SPINATUS. THAT WAS SEEN WHEN THEY TOOK AN X-RAY. THEY DECIDED NOT TO DO A SECOND SURGERY AND LEFT THE LITTLE PIECE IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21461318 ↗
• MalfunctionDec 11, 2024Break; Break

  ON 11/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13999HDN SCORPION NEEDLE TIP BROKE WHEN IT WAS FIRED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902489 ↗
• MalfunctionJul 8, 2024Break; Break

  ON 6/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT (QTY. 2) OF AN AR-13999HDN HD SCORPION NEEDLE HAD AN ISSUE WHEN PASSING THROUGH THE SCORPION MULTI FIRE HANDLE; IT WOULD BECOME STUCK AND HAD ANOTHER NEEDLE TIP BREAK OFF. ALL PIECES WERE RECOVERED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER AR-13999HDN HD SCORPION NEEDLE AND SCORPION. NO ADVERSE EFFECTS WERE REPORTED ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 6/18/2024: THERE WAS NO ADDITIONAL STEPS ADDED OR ANESTHESIA OR DELAY. THIS OCCURRED ON (B)(6) 2024 DURING A SHOULDER ARTHROSCOPY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689975 ↗
• MalfunctionJul 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6/12/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT (QTY. 2) OF AN AR-13999HDN HD SCORPION NEEDLE HAD AN ISSUE WHEN PASSING THROUGH THE SCORPION MULTI-FIRE HANDLE; IT WOULD BECOME STUCK, AND ANOTHER NEEDLE BROKE OFF AT THE TIP. ALL PIECES WERE RECOVERED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LOT NUMBER OF THE AR-13999HDN HD SCORPION NEEDLE AND SCORPION HANDLE DEVICE. NO ADVERSE EFFECTS WERE REPORTED ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 6/18/2024: THERE WAS NO ADDITIONAL STEPS ADDED OR ANESTHESIA OR DELAY. THIS OCCURRED ON (B)(6) 2024 DURING A SHOULDER ARTHROSCOPY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689798 ↗
• MalfunctionJul 8, 2024Break; Break

  ON 6/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-13999MF FASTPASS SCORPION HAD AN ISSUE WITH THE AR-13999HDN HD SCORPION NEEDLE; THE TIP OF THE HD SCORPION NEEDLE BROKE, AND ALL PIECES WERE RECOVERED FROM THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-13999HDN HD SCORPION NEEDLE AND AR-13999MF FASTPASS SCORPION HANDLE. THERE WAS NO DELAY TO THE CASE FOR THE RECOVERY OF THE NEEDLE AND NO ADDITIONAL STEPS ADDED OR ANESTHESIA. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689410 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE SCORPION NEEDLE BROKE. THE DEVICE BROKE INSIDE THE PATIENT BUT ALL PARTS WERE RETRIEVED. 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 19622341 ↗
• MalfunctionApr 22, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 03/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06524621 THAT AN AR-13999HDN HD SCORPION NEEDLE WAS COMPLETELY BENT WHEN PASSING THE SUTURE. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER AR-13999HDN WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154141 ↗
• MalfunctionMar 28, 2024Break; Break

  ON 03/13/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AR-13999MF FASTPASS SCORPION WAS DIFFICULT TO FIRE THE SCORPION NEEDLE WHEN PASSING SUTURE THROUGH DERMAL GRAFT AND (1) AR-13995N MULTIFIRE SCORPION NEEDLE TIP BROKE ALONG WITH (2) AR-13999HDN HD SCORPION NEEDLE WITH MEGALOADER. ALL TIPS OF THE BROKEN NEEDLES WERE RETRIEVED. A NEW SCORPION WAS OPENED/LOADED WITH AN HD NEEDLE, AND THE SURGERY COULD CONTINUE AND BE COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A SCR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991226 ↗
• MalfunctionMar 28, 2024Break; Break

  ON 03/13/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AR-13999MF FASTPASS SCORPION WAS DIFFICULT TO FIRE THE SCORPION NEEDLE WHEN PASSING SUTURE THROUGH DERMAL GRAFT AND (1) AR-13995N MULTIFIRE SCORPION NEEDLE TIP BROKE ALONG WITH (2) AR-13999HDN HD SCORPION NEEDLE WITH MEGALOADER. ALL TIPS OF THE BROKEN NEEDLES WERE RETRIEVED. A NEW SCORPION WAS OPENED/LOADED WITH AN HD NEEDLE, AND THE SURGERY COULD CONTINUE AND BE COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A SCR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991218 ↗
• MalfunctionMar 7, 2024Break; Break

  ON 02/21/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-13999HDN SCORPION NEEDLE TIP BROKE OFF. THE PIECE REMAINS INSIDE THE PATIENT. THIS OCCURRED DURING USE IN A CASE. DOCTOR ELECTED TO BYPASS X-RAY CONFIRMATION OF NEEDLE TIP PLACEMENT IN PATIENT AS WELL AS ANY SURGICAL INTERVENTION AS IT WOULD BE MORE TRAUMATIC TO ATTEMPT TO REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18857962 ↗
• MalfunctionJan 29, 2024Break; Break

  ON 01/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13999HDN SCORPION NEEDLE BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED ON 1/24/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595439 ↗
• MalfunctionJan 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  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 18442839 ↗
• MalfunctionDec 27, 2023Break; Break

  ON 11/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06414154 THAT AN AR-13999HDN HD SCORPION NEEDLE TIP BROKE OFF AND WAS NEVER LOCATED. IT IS NOT KNOWN IF IT FELL INSIDE THE PATIENT OR NOT. A SECOND AR-13999HDN HD SCORPION NEEDLE WAS BROUGHT IN AND THE PACKAGING WAS NOTICED NOT TO BE COMPLETELY SEALED, BUT IT WAS NEVER CLOSE TO THE FIELD. A THIRD AR-13999HDN HD SCORPION NEEDLE WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18399507 ↗
• MalfunctionDec 27, 2023Unsealed Device Packaging; Unsealed Device Packaging

  ON 11/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13999HDN HD SCORPION NEEDLE TIP BROKE OFF AND WAS NEVER LOCATED. IT IS NOT KNOWN IF IT FELL INSIDE THE PATIENT OR NOT. A SECOND AR-13999HDN HD SCORPION NEEDLE WAS BROUGHT IN AND THE PACKAGING WAS NOTICED NOT TO BE COMPLETELY SEALED, BUT IT WAS NEVER CLOSE TO THE FIELD. A THIRD AR-13999HDN HD SCORPION NEEDLE WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18399426 ↗
• MalfunctionOct 25, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06045007 THAT AN AR-13999HDN HD SCORPION NEEDLE WITH MEGALOADER, VE5, HAD AN ISSUE. THE SURGEON WAS COMPLETING AN AFLEX 301 PATCH OVER A ROTATOR CUFF, SIDE-SIDE REPAIR. THE SURGEON PLACED AND TIED 3 SUTURETAPES, STARTING ANTEROLATERAL AND MOVING POSTERIORLY. ON ATTEMPTING TO PLACE A FINAL SUTURE TAPE ON THE POSTEROLATERAL CORNER OF THE PATCH/CUFF TISSUE, THE DISTAL 8-9MM OF THE HD SCORPION NEEDLE BROKE OFF, CUTTING THE SUTURE. ON PULLING THE SCORPION OUT OF THE JOINT, THE BROKEN NEEDLE TIP FLEW OUT AND LANDED ON THE BACK SCRUB TABLE. THE SURGEON STATED AFTER THE CASE, ¿I FELT THE NEEDLE BEND AS I FIRED IT THROUGH THE PATCH.¿ THE CASE WAS COMPLETED USING ANOTHER AR-13999HDN HD SCORPION NEEDLE AND SEVERAL PACKS OF AR-7501 WITH A DELAY OF 4-5 MINUTES WHILE RETRIEVING AND OPENING A NEW SCORPION HD NEEDLE. THERE WAS NO ADDITIONAL ANESTHESIA NEEDED. THIS WAS DISCOVERED DURING ROTATOR CUFF REPAIR WITH A PATCH AUGMENTATION PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18005508 ↗
• MalfunctionOct 25, 2023Break; Break

  ON 9/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06044876 THAT AN AR-13999HDN HD SCORPION NEEDLE HAD AN ISSUE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023. THE NEW HD SCORPION NEEDLE BROKE OFF IN THE CUFF. THE BROKEN PIECE WAS NOT RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/12/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: ANOTHER AR-13999HDN HD SCORPION NEEDLE WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS VERY LITTLE TO NO CASE DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18002253 ↗