Arthrex® AR-13999MFFRecalls & reported problems
Arthrex, Inc. · FastPass Scorpion SL-MF with FlushPort · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex FastPass Scorpion SL-MF suture passer is a hand-operated orthopedic instrument used to place and release sutures during shoulder arthroscopy. Its 37 reports mostly describe the jaws sticking or refusing to close fully on the suture, plus a few cases of jamming, corrosion, and needle tips breaking off during rotator cuff repair. No deaths and no injuries are reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867293410), received between Aug 8, 2022 and Feb 16, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (19 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close19
- Physical Resistance/Sticking10
- Break3
- Mechanical Jam3
- Corroded1
- Defective Device1
- Detachment of Device or Device Component1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Difficult to Open or Close
IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, THE JAW OF THE DEVICE STOPPED FULLY CLOSING AFTER AN AUDIBLE CLICK. 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 24344974 ↗MalfunctionFeb 12, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, THE JAW DID NOT CLOSE COMPLETELY. THEREFORE, THE CUFF COULD NOT BE GRIPPED AND THE NEEDLE COULD NOT BE SUCCESSFULLY RELEASED. 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 24327729 ↗MalfunctionFeb 12, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, THE JAW DID NOT CLOSE COMPLETELY. THEREFORE, THE CUFF COULD NOT BE GRIPPED AND THE NEEDLE COULD NOT BE SUCCESSFULLY RELEASED. 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 24327726 ↗MalfunctionJan 15, 2026Use of Device Problem
IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF THE NEEDLE BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. FURTHER INFORMATION WAS REQUESTED. UPDATE 14-JAN-2026: IT WAS REPORTED THAT DURING THE ARTHROSCOPIC ROTATOR CUFF REPAIR, THE TIP OF THE NEEDLE BROKE OFF. THE BROKEN PIECE WAS 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. UPDATE 14-JAN-2026: THE SURGERY WAS DELAYED BY 45 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24081221 ↗MalfunctionJan 9, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THERE WAS A PROBLEM WITH THE JAWS OF THE SCORPION. NO PART OF THE DEVICE BROKE OFF. 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. ***UPDATE 02-JAN-2025 IT WAS CONFIRMED THAT THE JAWS WERE REGULARLY JAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019121 ↗MalfunctionDec 17, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, THE JAWS DID NOT GRAB THE SUTURE. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829481 ↗MalfunctionDec 15, 2025Difficult to Open or Close; Difficult to Open or Close
NO COMPLAINT ALLEGATION WAS PROVIDED. ALSO, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WILL BE PROCESSED AS REPAIR, NOT AS COMPLAINT. *** UPDATE 02-DEZ-2025 VBU: IT WAS REPORTED THAT THE DEVICE DOES NOT CLOSE ANYMORE. *** 12-DEC-2025 MAJUNG: FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE DEVICE DID NOT CLOSE ANYMORE. NO PARTS BROKE OFF THE DEVICE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH USING 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 23806100 ↗MalfunctionDec 1, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED DURING THE SHOULDER ARTHROSCOPY THAT THE JAW OF THE DEVICE DID NOT CLOSE TO CATCH THE SUTURE. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679124 ↗MalfunctionNov 21, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A SURGERY THE SCORPION JAWS DID NOT CLOSE PROPERLY. THIS RESULTED IN THE SUTURE NOT BEING FIRED CORRECTLY AND THE TWO DEVICES BEING UNUSABLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617642 ↗MalfunctionNov 21, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A SURGERY THE SCORPION JAWS DID NOT CLOSE PROPERLY. THIS RESULTED IN THE SUTURE NOT BEING FIRED CORRECTLY AND THE TWO DEVICES BEING UNUSABLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617542 ↗MalfunctionNov 5, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC CUFF REPAIR SURGERY THE JAWS OF THE DEVICE WOULD NOT CLOSE PROPERLY AND WOULD NOT CAPTURE THE SUTURE PROPERLY. 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 23475612 ↗MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A SURGERY THAT THE A SCREW FELL OUT OF THE DEVICE AND DISASSEMBLED IT. THE SCREW OR ANY OTHER PARTS DID NOT FALL INTO 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. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ON (B)(6) 2025 (B)(6): FURTHER INFORMATION RECEIVED THAT THE FINGER SPRING AND ONE HANDLE PIN WHICH HOLD THE FINGER WERE FELL OUT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22794274 ↗MalfunctionFeb 26, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE FRONT TRIGGER WOULD NOT PROPERLY CLOSE THE JAWS OF THE DEVICE. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471186 ↗MalfunctionFeb 19, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE JAW OF THE DEVICE DID NOT FULLY CLOSE AND THE SUTURE WAS NOT CAPTURED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21410003 ↗MalfunctionNov 14, 2024Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE JAW OF THE SCORPION DEVICE DID NOT CLOSE AFTER ONE USE. PER COMPLAINT REPORTER THERE WAS 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 20682716 ↗MalfunctionNov 14, 2024Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE JAW OF THE SCORPION DEVICE DID NOT CLOSE AFTER ONE USE. PER COMPLAINT REPORTER THERE WAS 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 20682715 ↗MalfunctionNov 14, 2024Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE JAW OF THE SCORPION DEVICE DID NOT CLOSE AFTER ONE USE. PER COMPLAINT REPORTER THERE WAS 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 20682713 ↗MalfunctionNov 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE JAW OF THE SCORPION DEVICE DID NOT CLOSE AFTER ONE USE. PER COMPLAINT REPORTER THERE WAS 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 20682707 ↗MalfunctionOct 3, 2024Break; Break
IT WAS REPORTED THE DEVICE KEEPS BREAKING THE NEEDLES. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE DW 25-SEP-2024: FURTHER INFORMATION WAS RECEIVED THAT THE NEEDLE IN USE WITH THE PLIER BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20358388 ↗MalfunctionSep 16, 2024Failure to Advance; Failure to Advance
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 20228547 ↗MalfunctionJun 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SCORPION NEEDLE GOT STUCK IN THE UPPER JAW OF THE PUNCH (FORCEPS). THE PUNCH (FORCEPS) WAS STUCK IN THE ROTATOR CUFF GRIP POSITION AND COULD NOT GET OUT OF THE JOINT WITH THE INSTRUMENT. THE SURGEON THEN BROKE THE NEEDLE ON PURPOSE TO BE ABLE TO REOPEN THE PUNCH (FORCEPS). THE 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 19574025 ↗MalfunctionJun 20, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE PROCEDURE THE TONG DID NOT RELEASE. THE NEEDLE WAS DEFLECTED AND IT WAS NOT POSSIBLE TO WORK PRECISELY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19573954 ↗MalfunctionJun 19, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE CUSTOMER HAS A DAMAGED CONSIGNED FASTPASS SCORPION SL AR-13999MFF # (10520769). THE INSTRUMENT JUST SEIZED UP AND THE JAW WILL NOT CLOSE FULLY. THERE IS NO SIGN OF DAMAGE AND OILING DOES NOT MAKE A DIFFERENCE. 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 19570228 ↗MalfunctionJun 17, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SURGEON FELT A CLICK AS THE NEEDLE PASSED THROUGH THE CUFF. WHEN THE FORCEPS CAME OUT, IT WAS NO LONGER POSSIBLE TO CLOSE THEM COMPLETELY. THE INITIAL ACTION OF GRASPING THE TENDON WAS THEREFORE NO LONGER POSSIBLE. WHEN THE SECOND DEVICE WAS USED, THE SCENARIO WAS REPEATED. NO PART OF THE DEVICES BROKE OFF. 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 19549024 ↗MalfunctionJun 17, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SURGEON FELT A CLICK AS THE NEEDLE PASSED THROUGH THE CUFF. WHEN THE FORCEPS CAME OUT, IT WAS NO LONGER POSSIBLE TO CLOSE THEM COMPLETELY. THE INITIAL ACTION OF GRASPING THE TENDON WAS THEREFORE NO LONGER POSSIBLE. WHEN THE SECOND DEVICE WAS USED, THE SCENARIO WAS REPEATED. NO PART OF THE DEVICES BROKE OFF. 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 19548603 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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