Arthrex® AR-2600SBS-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867027312), received between Dec 13, 2017 and Jan 8, 2026 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING A SPEED BRIDGE SURGERY THE SCREW BROKE WHEN IT WAS INSERTED. 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 24003637 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR BROKE DURING INSERTION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770879 ↗
• MalfunctionOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY THE BLUE HANDLE OF THE PUNCH FROM THE SPEEDBRIDGE¿ IMPLANT SYSTEM AR-2600SBS-4 (LOT: 14325652) GOT LOOSE FROM THE SHAFT AND COULD BE ROTATED WITHOUT THE SHAFT. THE BONE QUALITY WAS GOOD. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438551 ↗
• MalfunctionFeb 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR DETACHED FROM THE SCREW. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A 5.5 SWIVEL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471026 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE ANCHOR BROKE INSIDE THE PATIENT AFTER TWO ROTATIONS AND THE SUTURE TORE. ALL PARTS WERE RETRIEVED. 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 20238982 ↗
• InjuryJun 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL ROTATOR CUFF SUTURE SURGERY ON (B)(6) 2019 THE PATIENT STARTED TO EXPERIENCED MAJOR PROBLEMS (REDNESS, ITCHING AND PARTIALLY OPEN AREAS) AT THE OPERATED SITE. NO FURTHER INFORMATION RECEIVED. UPDATE DW 29-MAY-2024: THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019 IN UKH KLAGENFURT AND AN MEDICAL EXAMINATION WILL BE PERFORMED ON (B)(6) 2024 IN UKH GRAZ.

  Patient problems: Itching Sensation

  MAUDE report 19588226 ↗
• MalfunctionJun 18, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING SPEEDBRIDGE SURGERY THE BLUE HANDLE OF THE SINGLE-USE TRIM FROM THE SPEEDBRIDGE SET IS LOOSENING OFF THE INNER METAL SPIKE, HENCE AFTER HAMMERING IT COULD NOT BE REMOVED EASILY ANYMORE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. 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 19558818 ↗
• MalfunctionJun 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING HIP SPEED BRIDGE SURGERY THE PUNCH WITH THE BLUE HANDLE OVER TWISTED WHILE TRYING TO TWIST IT OUT. IT WAS NOT POSSIBLE TO PULL IT BACK AND HAD TO USE GREATER FORCE WITH THE HAMMER AND TONGS AGAINST THE BLUE PLASTIC TO GET THE PUNCH BACK OUT OFF THE BONE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. 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 19525328 ↗
• MalfunctionMay 16, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON USED THE PROVIDED DISPOSABLE PUNCH TO PREPARE THE BONE FOR THE SWIVELOCK ANCHORS WHEN COMPLETING A SPEEDBRIDGE CUFF REPAIR. THE SHAFT OF THE PUNCH WOULD TWIST WITHIN THE PLASTIC HANDLE, WHICH WOULD THEN MAKE IT DIFFICULT/IMPOSSIBLE TO TURN CLOCKWISE/ANTICLOCKWISE TO FACILITATE REMOVAL OF THE PUNCH FROM THE BONE. THE SURGEON HAD TO FORCEFULLY BACK OUT RATHER THAN TWIST OUT. 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 19335008 ↗
• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SPEED BRIDGE ROTATOR CUFF REPAIR SURGERY THE TAP BLUE HANDLE IS COMING LOOSE FROM THE METAL SHAFT ON INSERTION. THIS WAS MAKING IT DIFFICULT TO REMOVE THE PUNCH UNLESS A MOLE CLAMP IS USED. BY USING THE MOLE CLAMP THEY ARE THEN WIDENING THE PUNCHED HOLE RISKING THE SWIVEL LOCK NOT SETTING INTO BONE. THERE WAS NO VERTICAL MOVEMENT, ONLY ROTATIONAL. THE FAILURE WAS ONLY NOTICED AFTER USING THE MALLET AND INSERTING INTO THE BONE. 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 DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326012 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A SPEEDBRIDGE ROTATOR CUFF REPAIR SURGERY THE SHAFT OF THE PUNCH BECAME LOOSE SUCH THAT MANIPULATING THE HANDLE WAS NOT AFFECTING THE PUNCH AND THE HANDLE WAS JUST SPINNING ON THE METAL SHAFT. THEREFORE THE SURGEON COULD NOT DISLODGE THE PUNCH FROM THE PREPARED BONE BY TWISTING AND BACKING IT OUT INSTEAD HE HAD TO PULL OUT DIRECTLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH 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 19310605 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A SUPERIOR CAPSULAR RECONSTRUCTION SURGERY THE BLUE HANDLE FROM THE PUNCH BECAME DETACHED FROM THE METAL SHAFT WHEN IT WAS INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. A DRILL FROM ANOTHER ANCHOR SYSTEM HAD TO BE USED UNTIL A NEW KIT WAS BROUGHT INTO THE HALL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 14-MAR-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT HT EVENT OCCURRED ON (B)(6) 2022 AND THAT NO PATIENT WAS HARMED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270778 ↗
• MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-2600SBS-4 SPEED BRIDGE IMPLANT SYSTEM HAD THE HANDLE FALL OFF THE PUNCH. THIS WAS DISCOVERED DURING USE IN A PROCEDURE PERFORMED ON (B)(6) 2021. THE CASE WAS COMPLETED BY OPENING ANOTHER DEVICE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201128 ↗
• MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE PUNCH HANDLE DISENGAGED FROM PUNCH ITSELF, SO THE HANDLE WAS SPINNING WHEN TRYING TO REMOVE. IT TOOK A LONG TIME TO REMOVE. 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. UPDATE SWIT 12-FEB-2024: IT WAS THE PUNCH AR-1927PBS THAT WAS INSIDE THE AR-2600SBS-4 SPEEDBRIDGE PACK. SURGERY WAS FINISHED, IT JUST TOOK FIVE MINUTES TO REMOVE THE PUNCH FROM THE HARD BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803807 ↗
• MalfunctionFeb 26, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON 2/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2600SBS-4 SPEEDBRIDGE IMPLANT SYSTEM HAD AN ISSUE. WHILE USING THE BLUE SWIVLELOCK PUNCH THAT COMES WITH THE KIT, THE BLUE PLASTIC HANDLE DISASSOCIATED FROM THE METAL, RESULTING IN THE PUNCH BECOMING STUCK IN THE PILOT HOLE DUE TO THE SURGEON NOT BEING ABLE TO GET THE NECESSARY TORQUE/GRIP ON THE HANDLE TO REMOVE. THIS RESULTED IN THE SURGEON UTILIZING A PLIERS-LIKE TOOL TO GRIP THE METAL PART OF THE PUNCH AND MALLET IT OUT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION PROVIDED 2/21/24: THE PROCEDURE PERFORMED WAS A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED BY USING AN AR-1927PB. THE DEVICE WAS REMOVED USING A STERILE PLIERS. NO DELAY IN THE CASE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 18778164 ↗
• MalfunctionAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 7/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ONE OF THE SWIVELOCK FROM AN AR-2600SBS-4 SPEEDBRIDGE IMPLANT SYSTEM FAILED WHILE PRELOADING THE SUTURES. THE SWIVELOCK EYELETS BROKE AWAY FROM THE RETENTION SUTURE WHEN IT WAS BEING INSERTED IN THE CANNULA FOR IMPLANTATION. THE EYELET BROKE OFF WITHIN THE CANNULA AND NEVER MADE IT TO THE PATIENT'S BONE. THE EYELET NEVER FULLY BROKE OFF AND IT WAS BEING CONTAINED WITH THE SUTURES FROM THE SWIVELOCK THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK.

  Patient problems: Insufficient Information

  MAUDE report 17652556 ↗
• MalfunctionJul 17, 2023Break; Break

  ON 6/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE SWIVELOCK EYELET FROM AN AR-2600SBS-4 BROKE OFF DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17335336 ↗
• MalfunctionMar 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON(B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT ONE OF THE SWIVELOCK ANCHORS FROM AN AR-2600SBS-4 PULLED OUT AS THE SURGEON WAS FINISHING THE REPAIR BY TENSIONING DOWN A DOG EAR WHEN THE ANCHOR PULLED OUT. THE SURGEON CUT ALL THE SUTURES FROM THAT ANCHOR AND REMOVED IT ALTOGETHER. THE EYELET OF THE ANCHOR BECAME LOOSE WHEN THE SUTURE WAS RELEASED AND COULD NOT BE FOUND. TWO MORE ANCHORS WERE OPENED TO COMPLETE THE DOUBLE-ROW REPAIR. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16565149 ↗
• MalfunctionOct 3, 2022Break; Positioning Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2600SBS-4 SPEEDBRIDGE¿ IMPLANT SYSTEM WITH BIOCOMPOSITE SWIVELOCK¿ HAD AN ISSUE. DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022, THE SURGEON WAS TRYING TO IMPLANT THE DEVICE, THE ANCHOR BODY WAS NOT SITTING CORRECTLY INSIDE THE BONE YET AND HAD NOT BEEN IMPLANTED FULLY WHEN PART OF THE ANCHOR BROKE INSIDE THE PATIENT. TWO-THIRDS OF THE ANCHOR WAS LEFT INSIDE THE PATIENT'S BONE AND THE SURGEON DEEMED IT TO BE AFFIXED SECURELY AND SEATED CORRECTLY, AND THE OTHER FRAGMENT WAS REMOVED FROM THE PATIENT. THE CASE WAS THEN COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534505 ↗
• MalfunctionOct 3, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2600SBS-4 SWIVELOCK ANCHOR BROKE DURING INSERTION. TWO OF THE ANCHORS IN THIS TRAY BROKE. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534090 ↗
• MalfunctionApr 18, 2022Break

  ON 4/1/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2600SBS-4 SPEEDBRIDGE IMPLANT SYSTEM BIO-COMPOSITE SWIVELOCK EYELET BROKE OFF INSIDE THE PATIENT. SURGEON LOCATED THE BROKEN FRAGMENT AND WAS ABLE TO RETRIEVE IT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14136801 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE SURGEON WAS HITTING THE AWL THE PLASTIC HANDLE BECAME DETACHED FROM THE METAL PART OF THE AWL INSIDE. DUE TO THIS FAILURE AN MOLE GRIPS HAD TO BE USED TO REMOVE THE AWL OUT OF THE BONE WHICH RESULTED IN A DILATION OF THE AWL HOLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14074997 ↗
• MalfunctionFeb 7, 2022Difficult to Remove; Mechanical Jam

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-2324BCC-2 SWIVELOCK MEDIAL ANCHORS WERE PLACED SUCCESSFULLY, AS WELL AS THE FIRST LATERAL ANCHOR. HOWEVER WHEN SHUTTLING THE SECOND LATERAL ANCHOR DOWN THE FIBERTAPE SUTURES, THE EYELET SLID RIGHT OFF OF THE ANCHOR. SURGEON REMOVED THE DRIVER AND WAS ABLE TO SUCCESSFULLY REMOVE THE EYELET. SALES REPRESENTATIVE HAD SURGEON PULL THE ORANGE TAB AND TRY TO TUG ON THE EYELET SUTURE TO SEE IF IT WAS BROKEN, HOWEVER THE EYELET STITCH WAS STUCK ON SOMETHING INSIDE THE DRIVER, AND COULD NOT BE REMOVED AT ALL. THE CASE WAS COMPLETED USING AN AR-2324BCC-2 SWIVELOCK WITH NO FURTHER ISSUES. THIS WAS DISCOVERED DURING A RCR PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13471453 ↗
• MalfunctionOct 26, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE REMOVED 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: Insufficient Information

  MAUDE report 12696714 ↗
• MalfunctionJun 28, 2021Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY IT WAS NOT POSSIBLE TO IMPLANT THE DEVICE AND DURING ROTATION THE DEVICE BROKE AND GOT LOOSE INSIDE THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-2323BCC-1). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12075299 ↗