Arthrex® AR-16992Recalls & reported problems
Arthrex, Inc. · CapsuleClose Scorpion · Class 1
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867212688), received between Apr 13, 2021 and Jul 14, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Break” (12 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.
Reports received per month
Most reported problems
Device problems
- Break12
- Material Twisted/Bent3
- Device Damaged by Another Device1
- Difficult to Open or Close1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information9
- Foreign Body In Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Break
ON 19-JUN-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-16992 CAPSULECLOSE SCORPION EXPERIENCED THE NEEDLE BREAKING INSIDE THE PATIENT WHEN TRYING TO CLOSE THE DEVICE DURING A HIP SCOPE. A NEW DEVICE AND NEEDLE WERE OPENED TO FINISH THE PROCEDURE SUCCESSFULLY AND THE NEEDLE FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815188 ↗MalfunctionDec 29, 2025Difficult to Open or Close; Difficult to Open or Close
ADDITIONAL INFORMATION PROVIDED: IT WAS FURTHER REPORTED THIS OCCURRED DURING A HIP CX PROCEDURE WITH NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23907508 ↗MalfunctionDec 26, 2025Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-16992 CAPSULECLOSE SCORPION PART THAT CATCHES THE NEEDLE WAS BENT BACK AND THE DEVICE IS NOT USABLE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895553 ↗MalfunctionDec 26, 2025Break; Break
ON 12/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-16992 CAPSULECLOSE SCORPION TIP BROKE OFF WHILE ATTEMPTING TO PASS SUTURE THROUGH THE CAPSULE. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE WITH NO PATIENT HARM REPORTED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT SAFELY AND THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895416 ↗MalfunctionJul 14, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE THAT AN AR-16992 TIP BROKE INSIDE THE HIP. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY PROCEDURE. AFTER PULLING OUT THE INSTRUMENT, 2 MORE PIECES CAME OFF, ONE WAS THE SPRING. THE 1 PIECE THAT DETACHED INSIDE THE BOY WAS TAKEN OUT. THE OTHER TWO PIECES DETACHED OUTSIDE THE BODY WHEN THE HOSPITAL NURSE PASSED THE INSTRUMENT BACK TO THE SCRUB NURSE. THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493770 ↗MalfunctionJun 18, 2025Break; Break
ON 27 MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT THE TIP OF AN AR-16992 CAPSULECLOSE SCORPION BROKE INSIDE THE HIP JOINT. THE BROKEN PIECE WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER. THERE WAS NO RESIDUAL PIECE IN THE JOINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22282722 ↗MalfunctionFeb 12, 2025Material Twisted/Bent; Material Twisted/Bent
ON 01/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-16992 CAPSULECLOSE SCORPION WAS BENDING THE AR-16992N SCORPION NEEDLE AND TWISTING THE SUTURE EVERY TIME IT WAS FIRED. NOTHING BROKE INSIDE THE PATIENT. NO CASE DELAY WAS REPORTED, AND IT IS UNKNOWN IF ADDED ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER AR-16992 CAPSULECLOSE SCORPION. NO PHOTOS WERE TAKEN OF THE ISSUE. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON 01/15/2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/24/2025: A (QTY. 2) OF AN AR-16992N SCORPION NEEDLE WAS USED IN THE PROCEDURE. BOTH NEEDLES DID NOT BREAK INSIDE THE CASING; THEY ONLY BENT. THE PART AND LOT NUMBER OF THE FIBERWIRE USED IN THE PROCEDURE ARE UNKNOWN. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21366400 ↗MalfunctionJun 14, 2024Break; Break
IT WAS REPORTED THAT THE (B)(6) SCORPION IS BROKEN. NO ADVERSE EFFECT TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19539614 ↗MalfunctionMay 6, 2024Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPIC PROCEDURE, THE CLAMP LOCKS AND DAMAGED THE SUTURE. THE CASE WAS COMPLETED BY USING A DIFFERENT DEVICE.
Patient problems: Insufficient Information
MAUDE report 19249825 ↗MalfunctionAug 1, 2023Break; Break
ON 07/03/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-16992 CAPSULECLOSE SCORPIONS FRONT JAW BROKE, IT'S CRACKED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17434077 ↗MalfunctionMay 16, 2023Break; Break
ON 04/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-16992 CAPSULECLOSE SCORPION NEEDLE BROKE OFF. THIS WAS DISCOVERED DURING A CASE AND DEVICE BROKE DURING USE. PER FACILITY: "WHEN CLOSING THE CAPSULE IN THE HIP THE DOCTOR CLOSED THE SCORPION AND FIRED THE NEEDLE THROUGH THE CAPSULE AND THE SUTURE DIDN'T PASS. WHEN HE PULLED THE SCORPION OUT OF THE PORTAL THE TIP WAS BROKEN OFF THE SCORPION. PICTURE IS ATTACHED. I WAS IN THE CASE AND ASKED HIM IF HE SQUEEZED THE DEVICE EXTREMELY HARD AND HE SAID NO."
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 16939112 ↗MalfunctionMar 8, 2022Break; Material Twisted/Bent
ON 10/26/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-16992 SCORPION BROKE. THIS OCCURRED DURING A CASE WHEN IT WAS FOUND THAT THE DISTAL TIP IS BENT/BROKEN AND WILL NOT ACCEPT THE NEEDLE. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: Insufficient Information
MAUDE report 13689799 ↗MalfunctionDec 21, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(6) THAT AN AR-16992 CAPSULECLOSE SCORPION'S TIP BROKE. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 13054603 ↗MalfunctionJul 27, 2021Material Fragmentation
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPIC PROCEDURE, WHEN THE SURGEON WAS ATTEMPTING TO PASS A #2 FIBERWIRE WITH THE CAPSULE CLOSE SCORPION, AR-16992, THE TIP OF THE INSTRUMENT BROKE INTO 3 PIECES IN THE JOINT. THE SURGEON WAS ABLE TO RETRIEVE THE 3 BROKEN PIECES FROM THE JOINT AND FOLLOW UP X-RAYS WERE TAKEN TO ENSURE NOTHING WAS MISSED. THE CASE WAS COMPLETED BY USING ANOTHER SCORPION.
Patient problems: Insufficient Information
MAUDE report 12231919 ↗MalfunctionJun 14, 2021Break
IT WAS REPORTED DURING A HIP PROCEDURE, AFTER INSERTION THE TIP OF THE AR-16992, SCORPION BROKE OFF. THE SURGEON USED GRASPERS TO REMOVE THE BROKEN PIECE. THE CASE WAS COMPLETED USING A COMPETITOR PRODUCT. THE INCIDENT ADDED 15 MINUTES TO THE PROCEDURE REQUIRING ADDITIONAL ANESTHESIA.
Patient problems: Insufficient Information
MAUDE report 11990327 ↗MalfunctionMay 24, 2021Break
IT WAS REPORTED THAT THE TIP OF THE AR-16992 SCORPION BROKE OFF. THE SALES REP REPORTED THE CASE WAS COMPLETED WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11872417 ↗MalfunctionApr 13, 2021Break
IT WAS REPORTED DURING A HIP SCOPE PROCEDURE THE SURGEON WAS USING THE AR-16992 SCORPION AND A FIBERWIRE TO CLOSE THE CAPSULE. AS THEY WENT TO FIRE THE NEEDLE TO PASS THE SUTURE THROUGH THE TISSUE, THE VERY TIP OF THE SCORPION BROKE OFF INSIDE THE JOINT WHILE THE NEEDLE REMAINED INTACT. THE SURGEON WAS ABLE TO USE A GRASPER AND PULL THE PIECE OF THE SCORPION OUT AND THERE WAS NO DELAY IN THE CASE.
Patient problems: Insufficient Information
MAUDE report 11655680 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.