Arthrex® AR-2600SBS-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867027329), received between Nov 3, 2016 and Dec 29, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 24, 2017Class IITerminated

   Some eyelets broke from SwiveLock Anchor on insertion.

   Z-2045-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE PUNCH (AR-1927PBS) OF THE SPEEDBRIDGE IMPLANT SYSTEM WAS LOOSE INSIDE THE HANDLE. THEREFORE IT WAS NOT POSSIBLE TO REMOVE BONE AS USUAL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY AND 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 18419685 ↗
• MalfunctionNov 21, 2023Unintended Movement; Unintended Movement

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT THE HANDLE OF THE PUNCH FROM AN AR-2600SBS-5 SPEEDBRIDGE IMPLANT SYSTEM WITH BIOCOMPOSITE SWIVELOCK SP WAS ROTATING WHILE TRYING TO PULL IT OUT AFTER MALLET TO PREPARE THE SOCKET. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON 10/24/2023. AFTER THE PUNCH WAS REMOVED, THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 18182028 ↗
• MalfunctionOct 23, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGERY THE BONE PUNCH OF THE DEVICE LOOSENED WHEN PUNCHING THE PILOT HOLE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17987291 ↗
• MalfunctionJul 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE BLUE HANDLE OF THE PUNCH FROM THE SPEEDBRIDGE KIT WAS NOT WORKING. THE HANDLE WAS NOT FIXED TO THE METAL, SO WHEN THEY TRIED TO REMOVE THE PUNCH FROM BONE, ONLY THE HANDLE ROTATED, NOT THE METAL PART. IT WAS HARD FOR THEM TO REMOVE THE PUNCH FROM THE PATIENT. 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 17350927 ↗
• InjuryNov 3, 2016Break

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE, THE SURGEON WAS ATTEMPTING TO USE THE AR-2600SBS-5, SPEEDBRIDGE IMPLANT SYSTEM WITH BIO-COMPOSITE SWIVELOCK. THE SURGEON WAS INSERTING THE WHITE THREADED SWIVELOCK ANCHOR OF THE IMPLANT SYSTEM. THE SWIVELOCK ANCHOR WAS IMPLANTED APPROXIMATELY TWO THIRDS OF THE WAY WHEN THE REMAINING ONE THIRD OF THE ANCHOR BROKE OFF. THE SURGEON PULLED ON THE TWO THIRDS PORTION OF THE ANCHOR THAT WAS IMPLANTED AND FELT IT WAS SECURE AND SUFFICIENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 6076879 ↗