Arthrex® AR-2600SBS-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867319745), received between Jun 2, 2020 and Jun 4, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Separation Problem; Separation Problem

  ON 11/10/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA PHONE THAT A PUNCH FROM AN AR-2600SBS-9 SPEEDBRIDGE IMPLANT SYSTEM, IS GETTING STUCK IN THE PATIENT BONE AND SURGEON IS HAVING DIFFICULTY REMOVING IT. AFTER MALLEATING THE PUNCH INTO THE BONE, AT THE TIME OF REMOVAL THE HANDLE STARTS SPINNING, AS IF IT DISENGAGES FROM THE SHAFT, AND SURGEON CANNOT GRASP IT. WITH THE USE OF PLIERS, THE PUNCH IS ABLE TO BE REMOVED AND A REUSABLE PUNCH IS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19459482 ↗
• MalfunctionApr 29, 2024Wrong Label; Wrong Label

  ON 3/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2600SBS-9 SPEEDBRIDGE IMPLANT SYSTEM OUT BOX LABEL STATED THAT EXPIRATION DATE IS APRIL OF 2022. WHEN THE PACKAGE WAS OPENED, THE INNER PACKAGE LABEL STATED THE EXPIRATION DATE IS MAY OF 2022. THE IMPLANTS WERE USED IN A RCR PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203463 ↗
• MalfunctionApr 15, 2024Expiration Date Error; Expiration Date Error

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2600SBS-9 SPEEDBRIDGE IMPLANT SYSTEM OUT BOX LABEL STATED THAT EXPIRATION DATE IS APRIL OF 2022. WHEN THE PACKAGE WAS OPENED, THE INNER PACKAGE LABEL STATED THE EXPIRATION DATE IS MAY OF 2022. THE IMPLANTS WERE USED IN A RCR PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19111006 ↗
• MalfunctionApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON 12/27/2022 BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-2600SBS-9 SPEEDBRIDGE IMPLANT SYSTEM BLUE HANDLE OF THE PUNCH CAME OFF. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082190 ↗
• InjuryJun 9, 2023Break; Break

  ON 5/16/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN INSTRUMENT FROM AN AR-2600SBS-9 SPEEDBRIDGE IMPLANT SYSTEM BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A HIP SCOPE PROCEDURE ON (B)(6) 2023. THE BROKEN PIECE REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17097197 ↗
• InjuryJun 2, 2020Break; Component Missing

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5094324) THAT THE FOLLOWING INCIDENT OCCURRED ON (B)(6) 2020: DISTAL PORT OF THE NEEDLE BROKE OFF DURING SURGICAL CASE. THE PART NUMBER LISTED IN THE LETTER WAS AR-2600BS9. THIS IS NOT A VALID ARTHREX PART NUMBER. A REQUEST HAS BEEN SENT TO THE FACILITY INCIDENT REPORTER REQUESTING CONFIRMATION OF THE PART NUMBER AND ADDITIONAL INFORMATION. ADDITIONAL INFORMATION OBTAINED 5/15/20: THE PROCEDURE WAS A SHOULDER ARTHROSCOPY, ROTATOR CUFF REPAIR. THE PART NUMBER IS CONFIRMED TO BE AR-2600SBS-9 (LOT 10430732). AN X-RAY WAS TAKEN AND NO FOREIGN BODY WAS FOUND HOWEVER THE FACILITY REPORTS THEY WERE UNABLE TO ACCOUNT FOR THE NEEDLE TIP. STAFF BELIEVES THE SALES REP GAVE A NEW DEVICE TO THE SURGEON TO COMPLETE THE PROCEDURE. THE DEVICE IS REPORTED, BY THE FACILITY, TO HAVE BEEN TAKEN BY THE SALES REP WHO WAS PRESENT DURING THE PROCEDURE. THE LOT NUMBER PROVIDED IS NOT A VALID MATCH TO THE CONFIRMED ARTHREX PART NUMBER PROVIDED. ADDITIONAL INFORMATION OBTAINED 5/18/20: THE SALES REP WHO WAS PRESENT HAS CONFIRMED THAT HE DID NOT TAKE THE DEVICE FROM THE FACILITY, NOR DID HE HAVE A REASON TO AS HE STATES HE HAD NO KNOWLEDGE OF THE DEVICE TIP BEING BRO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10109071 ↗