Arthrex® AR-2600SBS-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867319738), received between Mar 8, 2021 and Oct 3, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-13995N SCORPION¿ NEEDLE, AND AN AR-2600SBS-8 SPEEDBRIDGE¿ IMPLANT SYSTEM BROKE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20359277 ↗
• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE SCORPION NEEDLE BROKE-OFF INSIDE THE PATIENT. 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. UPDATE 22-SEP-2023 NROE: FURTHER INFORMATION REVEALED THAT THE TIP OF THE DEVICE COULD NOT BE RETRIEVED FROM THE PATIENT BECAUSE THE SURGEON COULD NOT FIND IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17908458 ↗
• InjuryMay 17, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED TO AN ARTHREX EMPLOYEE BY FDA AUDITOR STATING THAT A REPORT WAS SUBMITTED TO THE FDA STATING THAT ON (B)(6)2023, A PATIENT UNDERWENT A RIGHT ROTATOR CUFF REPAIR USING AN AR-2600SBS-8 SPEEDBRIDGE IMPLANT SYSTEM WITH SCORPION-MULTIFIRE NEEDLE. BATCH: 14469499, WHERE A SCORPION-MULTIFIRE NEEDLE TIP BROKE OFF IN THE SHOULDER OF THE PATIENT, AND THE FRAGMENTS WERE 1-2MM. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THERE IS A SMALL 1MM BY 0.5MM NEEDLE TIP WITHIN THE ROTATOR CUFF TISSUE OF THE PATIENT. AFTER SEVERAL FAILED ATTEMPTS TO RETRIEVE IT, THE SURGEON INTENTIONALLY LEFT IT THERE TO AVOID HARM. DIGGING IN THE ROTATOR CUFF AFTER IT HAD BEEN REPAIRED TO RETRIEVE THE NEEDLE TIP WOULD CAUSE EXTENSIVE DAMAGE TO THE CUFF. THE SURGEON SPENT TIME ENSURING THE BROKEN TIP WAS NOT WITHIN THE JOINT, WHICH WAS CONFIRMED WITH INTRA-OPERATIVE FLUOROSCOPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16946429 ↗
• MalfunctionJun 20, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2600SBS-8 SPEED-BRIDGE IMPLANT SYSTEM HAD AN ISSUE WITH THE SCORPION NEEDLE WITHIN THE KIT BREAKING. THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING A ROTATORY CUFF RESECTION PROCEDURE. NO HARM CAME TO THE PATIENT AND THE METAL PIECE WAS RETRIEVED. A NEW SCORPION WAS OPENED AND USED IN PLACE OF THE BROKEN ITEM TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744706 ↗
• MalfunctionMar 8, 2021Break

  IT WAS REPORTED, THAT DURING A ROTATOR CUFF REPAIR PROCEDURE TWO OF THE LATERAL AR-2600SPS-8 ANCHORS BROKE. ALL PIECES WERE REMOVED. THE CASE WAS COMPLETED USING 2-SINGLE WRAPPED ANCHORS.

  Patient problems: Insufficient Information

  MAUDE report 11435954 ↗