Arthrex® AR-13995N-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867283985), received between Oct 15, 2019 and Nov 21, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY USING SPEEDBRIDGE THE NEEDLE BENT WHEN THE SURGEON ATTEMPTED TO PASS IT THROUGH THE TISSUE. THE PATIENT'S TISSUE WAS REPORTED TO BE THICK OR FIBROUS. TO COMPLETE THE PROCEDURE, THE SURGEON USED A PENETRATOR AR-2167-2. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 23617957 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SCORPION DEVICE FAILED TO PASS A NUMBER OF TIMES WITH THE TIP INTACT, HOWEVER ON THE FINAL TIME THE SURGEON NOTICED THAT THE TIP OF THE SCORPION NEEDLE HAD BROKEN OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20225432 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY THE TIP BROKE OFF. THE DEVICE BROKE OFF BEFORE IT WAS INSERTED INTO THE PATIENT¿S BODY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566549 ↗
• MalfunctionJun 17, 2024Break; Break

  ***UPDATE AVOE (B)(6) 2024. IT WAS CONFIRMED THAT THE SURGEON DIDN'T FIND THE FRAGMENT IN THE PATIENT. X-RAY WAS PERFORMED FOR CONFIRMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546419 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE NEEDLE BROKE OFF INTRAOPERATIVELY. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19060839 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SCORPION NEEDLE BROKE DURING PASSAGE TROUGH THE SUPRASPINATUS. THE NEEDLE KNOCKED ON THE ACROMIUM SEVERAL TIMES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018334 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE NEEDLE BROKE WHILE SUTURING THE TENDON. THE BROKEN OFF PART COULD NOT BE RETRIEVED FROM THE PATIENT. 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. UPDATE AVOE 29-AUG-2023 IT WAS CONFIRMED THAT THE NEEDLE BROKE INSIDE THE PATIENT AND THE BROKEN PART WASN¿T FOUND.

  Patient problems: Foreign Body In Patient

  MAUDE report 17775620 ↗
• MalfunctionAug 23, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE NEEDLE BROKE DURING INSERTION. 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. ***UPDATE SWIT (B)(6) 2023: THE NEEDLE BROKE OFF INSIDE THE PATIENT. ALL BROKEN PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602465 ↗
• MalfunctionFeb 23, 2023Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SCORPION NEEDLE BROKE OFF FIRST TIME SHOOTING/SEWING. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 16427719 ↗
• MalfunctionAug 18, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13995N-1 BROKE DURING A ROTATOR CUFF PROCEDURE. WHILE PASSING THROUGH THE ROTATOR CUFF THE SURGEON REALIZED THE NEEDLE WAS BROKEN. THE TIP OF THE NEEDLE WAS IN THE SUB ACROMIAL SPACE OF THE SHOULDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15249808 ↗
• InjuryJul 29, 2020Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE SURGEON HAD TWO AR-13995N SCORPION NEEDLES THAT HAD ISSUE AND BROKE OFF DURING THE CASE. THE LOT NUMBER FOR BOTH NEEDLES WAS LOT 10674580 AND CAME FROM THE SAME BOX. ACCORDING TO THE STAFF, THE FIRST NEEDLE TIP WAS RETRIEVED BUT THE SECOND NEEDLE TIP WAS NOT. IT WAS REPORTED THAT IT IS PRESUMED TO HAVE BEEN SUCTIONED AWAY WITH THE NEPTUNE MACHINE, BUT IS NOT CONFIRMED. THE CASE WAS COMPLETED AS PLANNED. THE FACILITY DID NOT SAVE THE BROKEN NEEDLES. TWO NEEDLES WERE USED WHICH HAD ISSUE AND ARE NOT AVAILABLE TO RETURN. ONE FROM OPENED BOX WAS OPENED BY THE FACILITY TO VIEW THE NEEDLE AND USE FOR COMPARISON TO CONFIRM DEVICE RETRIEVALS AND IS NOT AVAILABLE TO RETURN. 2 REMAIN IN THE OPENED BOX. THE FACILITY WILL RETURN THE OPENED BOX WITH THE TWO UNOPENED NEEDLES AND IS SEEKING CREDIT FOR A TOTAL OF 5 NEEDLES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10337560 ↗
• InjuryOct 15, 2019Break

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE NEEDLE TIP BROKE OFF. THE SURGEON TRIED TO REMOVE THE BROKEN FRAGMENT BUT IT WAS NOT POSSIBLE. THE FRAGMENT WILL REMAIN INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. IT IS NOT POSSIBLE FOR THE CUSTOMER TO SEND BACK THE NEEDLE FOR EVALUATION BECAUSE HE LOST THE DEVICE IN-HOUSE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9193627 ↗