Arthrex® AR-2600SBS-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867369658), received between Oct 12, 2021 and Dec 3, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Break; Break

  ON 11/14/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT TWO 4.75 MM KNOTLESS SWIVELOCK ANCHORS FROM THE AR-2600SBS-10 KNOTLESS SPEEDBRIDGE IMPLANT SYSTEM FRACTURED DURING INSERTION. THE FIRST ANCHOR BROKE INTO THREE PIECES AFTER USE OF THE DISPOSABLE PUNCH. THE SECOND ANCHOR BROKE IN HALF FOLLOWING THE USE OF THE DISPOSABLE PUNCH AND SUBSEQUENT TAPPING. THE PROCEDURE WAS DELAYED APPROXIMATELY 10 MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. ALL ANCHOR FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT, AND AN AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK ANCHOR WAS USED TO COMPLETE THE CASE. THE ISSUE OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703564 ↗
• MalfunctionSep 12, 2024Break; Break

  ON 8/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE SWIVELOCKS FROM AN AR-2600SBS-10 KNOTLESS SPEEDBRIDGE IMPLANT SYSTEM BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

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

  MAUDE report 20200289 ↗
• MalfunctionJun 7, 2024Separation Problem; Separation Problem

  IT WAS REPORTED ON 12/29/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2600SBS-10 SPEEDBRIDGE SYSTEM LATERAL ANCHORS EYELET WOULD NOT STAY IN AND WAS LODGED IN THE INSERTER. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484421 ↗
• MalfunctionApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-2600SBS-10 SPEED BRIDGE DISENGAGED. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE WHEN THE HANDLE OF THE DISPOSABLE PUNCH DISENGAGED FROM THE METAL SPEAR DURING INSERTION TO CREATE A HOLE FOR THE ANTERIOR MEDIAL ANCHOR. THE SPEAR WAS REMOVED USING VICE GRIPS SINCE THE HANDLE SPUN INDEPENDENTLY OFF THE METAL SHAFT. THE CASE WAS COMPLETED USING A REUSABLE PUNCH FROM AN IN HOUSE SHOULDER TRAY. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/14/2021 : THE CASE WAS COMPLETED USING A STANDARD SILVER PUNCH FROM THE SHOULDER TRAY. THE BONE QUALITY OF THE PATIENT WAS ABOVE AVERAGE. ADDITIONAL INFORMATION PROVIDED ON 12/14/2021 : A ROTATOR CUFF REPAIR WAS BEING PERFORMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192013 ↗
• MalfunctionApr 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/13/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-2600SBS-10 SPEED BRIDGE DISENGAGED. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE WHEN THE HANDLE OF THE DISPOSABLE PUNCH DISENGAGED FROM THE METAL SPEAR DURING INSERTION TO CREATE A HOLE FOR THE ANTERIOR MEDIAL ANCHOR. THE SPEAR WAS REMOVED USING VICE GRIPS SINCE THE HANDLE SPUN INDEPENDENTLY OFF THE METAL SHAFT. THE CASE WAS COMPLETED USING A REUSABLE PUNCH FROM AN IN HOUSE SHOULDER TRAY. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/14/2021 : THE CASE WAS COMPLETED USING A STANDARD SILVER PUNCH FROM THE SHOULDER TRAY. THE BONE QUALITY OF THE PATIENT WAS ABOVE-AVERAGE. ADDITIONAL INFORMATION PROVIDED ON 12/14/2021 : A ROTATOR CUFF REPAIR WAS BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125598 ↗
• MalfunctionApr 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/27/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2600SBS-10 SPEEDBRIDGE IMPLANT SYSTEM 4.75 SWIVELOCK, AFTER BEING FULLY IMPLANTED, THE LOCKING MECHANISM CAME OUT WHEN SURGEON REMOVED THE INSERTER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19110694 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 3/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE EYELET OF ONE OF THE SWIVELOCKS FROM AN AR-2600SBS-10 KNOTLESS SPEEDBRIDGE¿ IMPLANT SYSTEM, WAS PULLED OUT. AFTER INSERTING THE SWIVELOCK SUCCESSFULLY, THE SURGEON WAS TRYING TO SHUTTLE A REPAIR SUTURE THROUGH THE SWIVELOCK LINK SHUTTLE STITCH, AND AS IT WAS BEING CONVERTED, THE EYELET PULLED OUT THROUGH THE CENTER OF THE SWIVELOCK, WHICH CAUSED A FAILURE OF THE KNOTLESS CONSTRUCT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH THE REST OF THE SWIVELOCKS FROM THE KIT. THE BROKEN EYELET WAS REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16608926 ↗
• InjuryJan 23, 2023Break

  ON 11/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN MULTIFIRE SCORPION NEEDLE TIP, FROM AN AR-2600SBS-10 KNOTLESS SPEEDBRIDGE IMPLANT SYSTEM, WAS FOUND TO BE BROKEN OFF, ON THE 6TH PASS ATTEMPT. AFTER SPENDING SOME TIME LOOKING FOR THE TIP OF THE NEEDLE, AN X-RAY HAD TO BE TAKEN TO HELP FIND THE BROKEN FRAGMENT. THE MULTIFIRE SCORPION NEEDLE TIP WAS FOUND OUTSIDE OF THE PATIENT, AND IT WAS CONFIRMED VIA X-RAY THAT NOTHING WAS LEFT INSIDE THE PATIENT. CASE WAS COMPLETED BY OPENING AN AR-7281 FREE NEEDLE. THIS WAS DISCOVERED DURING AN OPEN RCR PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 1/4/2023: PER THE SALES REPRESENTATIVE, PATIENT SPENT AN ADDITIONAL THIRTY MINUTES UNDER ANESTHESIA WHILE SURGEON WAS LOOKING FOR THE BROKEN NEEDLE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223176 ↗
• InjurySep 26, 2022Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2600SBS-10 SPEEDBRIDGE IMPLANT SYSTEM SUTURES RIPPED. WHILE CUTTING THE REPAIR SUTURE ON ONE OF THE ANCHORS IN THE KNOTLESS SPEEDBRIDGE KIT (AR-2600SBS-10, LOT: 13847017), THE SHUTTLING SUTURES FROM THE SAME ANCHOR RIPPED. THE MEDIAL PULLEY OF THE KNOTLESS SPEEDBRIDGE COULD NOT BE COMPLETED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484267 ↗
• MalfunctionOct 12, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-2600SBS-10 SPEEDBRIDGE IMPLANT SYSTEM SUTURE BROKE OFF FROM THE EYELET BEFORE THE SURGEON COULD PULL THE INSERTER OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-2600SBS-10.

  Patient problems: Insufficient Information

  MAUDE report 12616437 ↗