Arthrex® AR-16992NRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867219557), received between Sep 26, 2024 and Mar 3, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  ON 11-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-16992 SCORPION HAS A NEEDLE TIP BROKEN. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497038 ↗
• MalfunctionMar 3, 2026Break

  ON 11-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-16992N SCORPION NEEDLE HAS A BROKEN TIP. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496847 ↗
• MalfunctionAug 20, 2025Break; Break

  ON 08/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3636H SUTURE ANCHOR, AND (2) AR-16992N SCORPION¿ NEEDLES FAILED. THIS OCCURRED DURING A HIP LABRAL REPAIR ON (B)(6) 2025 WHEN THE AR-3636H REPAIR STITCH DID NOT PASS THROUGH THE ANCHOR. THE DEVICE WAS REMOVED AND ANOTHER AR-3636H WAS USED. THE (2) AR-16992N BROKE DURING THE FIRST PASS. ALL FRAGMENTS WERE RETRIEVED. THE CASE CONTINUED USING A AR-4068HL. THERE WAS ABOUT A 10-MINUTE DELAY WHERE ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE REPRESENTATIVE WAS UNSURE BUT SAID HE COULD GUESS THE BONE QUALITY WAS HARD.

  Patient problems: Insufficient Information

  MAUDE report 22852060 ↗
• MalfunctionAug 20, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3636H SUTURE ANCHOR, AND (2) AR-16992N SCORPION¿ NEEDLES FAILED. THIS OCCURRED DURING A HIP LABRAL REPAIR ON (B)(6) 2025 WHEN THE AR-3636H REPAIR STITCH DID NOT PASS THROUGH THE ANCHOR. THE DEVICE WAS REMOVED AND ANOTHER AR-3636H WAS USED. THE (2) AR-16992N BROKE DURING THE FIRST PASS. ALL FRAGMENTS WERE RETRIEVED. THE CASE CONTINUED USING AN AR-4068HL. THERE WAS ABOUT A 10-MINUTE DELAY WHERE ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE REPRESENTATIVE WAS UNSURE BUT SAID HE COULD GUESS THE BONE QUALITY WAS HARD.

  Patient problems: Insufficient Information

  MAUDE report 22852048 ↗
• MalfunctionFeb 12, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 01/21/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-(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 (B)(6) 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 21366402 ↗
• 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 (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: A (QTY. (B)(4)) 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 21366399 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HIP LABRAL REPAIR SURGERY THE NEEDLE BROKE WHILE TRYING TO PASS THE REPAIR SUTURE THROUGH THE HIP CAPSULE TISSUE. ALL PARTS WERE RETRIEVED. 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 20311322 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HIP LABRAL REPAIR SURGERY THE NEEDLE BROKE WHILE TRYING TO PASS THE REPAIR SUTURE THROUGH THE HIP CAPSULE TISSUE. ALL PARTS WERE RETRIEVED. 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 20311249 ↗