Arthrex® ABS-2010-OTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867338548), received between Feb 7, 2022 and Mar 5, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Break

  ON 12-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-2010-OT INTRAOSSEOUS BIOPLASTY (IOBP), CORE DECOMPRESSION & DELIVERY KIT HAD THE BLACK HANDLE OF THE BLACK T-HANDLE BREAK APART WHILE DRILLING. THIS WAS DISCOVERED DURING A HIP IOBP PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO PIECES BROKE OFF WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED 19-FEB-2026: IT WAS FURTHER REPORTED THE CASE WAS COMPLETED WITH A WRIGHT MEDICAL IOBP KIT AND A ONE-MINUTE DELAY WAS EXPERIENCED. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519246 ↗
• MalfunctionOct 23, 2025Break; Break

  ON 10/15/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-2010-OT IOBP HIP OPEN TIP PROCEDURE KIT DEVICE BROKE AND DID NOT DEPLOY. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369884 ↗
• MalfunctionMay 2, 2025Break; Break

  ON 4/18/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE TIP OF A FLIPCUTTER FROM AN ABS-2010-OT INTRAOSSEOUS BIOPLASTY CORE DECOMPRESSION DELIVERY KIT BROKE OFF. THE SURGEON ATTEMPTED REMOVAL AND COULD NOT, ULTIMATELY DETERMINE THAT LEAVING THE BROKEN TIP IN THE FEMORAL HEAD WAS THE BEST COURSE OF ACTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER COMPLICATIONS ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 21951266 ↗
• MalfunctionMar 12, 2025Break; Break

  ON 02/25/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-2010-OT INTRAOSSEOUS BIOPLASTY KIT HAD THE TIP OF THE DECOMPRESSION DEVICE BROKEN OFF WHEN TRYING TO REMOVE IT FROM THE PATIENT'S HIP. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP, WHICH STAYED IN THE PATIENT'S BONE. THEY WERE ABLE TO COMPLETE THE REMAINDER OF THE PROCEDURE. THIS WAS DISCOVERED DURING A CORE DECOMPRESSION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21584644 ↗
• MalfunctionFeb 19, 2025Break; Break

  ON 02/03/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-2010-OT INTRAOSSEOUS BIOPLASTYS TIP OF THE DECOMPRESSION DEVICE BROKE. THIS OCCURRED DURING A HIP IOBP PROCEDURE ON (B)(6) 2024, WHEN THE DEVICE BROKE OFF INSIDE THE PATIENT AND COULD NOT BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21409583 ↗
• MalfunctionNov 21, 2022Break

  IT WAS REPORTED THAT DURING A BIO-PLASTY OF THE HIP SURGERY, THE TIP OF THE DECOMPRESSION NEEDLE BROKE-OFF AND THE SURGEON WAS UNABLE TO USE THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE, PART NUMBER AR-1204AS-70. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834816 ↗
• MalfunctionFeb 14, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-2010-OT IOBP KIT HAD AN ISSUE. THE FLIP-CUTTING PIECE BROKE DURING A CASE. THE PIECE WAS RETRIEVED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13527012 ↗
• MalfunctionFeb 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ABS-2010-OT INTERNAL MECHANISM BROKE WHILE THE SURGEON WAS TRYING TO FLIP THE FLIPCUTTER FOR A DECOMPRESSION. THIS WAS DISCOVERED DURING A PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION RECEIVED 1/24/2022: THIS WAS DISCOVERED DURING AN IOBP PROCEDURE. DEVICE BROKE WHEN SURGEON TRIED TO FLIP THE FLIPCUTTER TO DECOMPRESS, THERE WAS A POP, AND THE FLIPCUTTER WOULD NOT FLIP NOR WOULD IT DRILL. THIS OCCURRED DURING USE; HOWEVER NO PIECES CAME LOOSE INSIDE THE PATIENT. SURGEON WAS ABLE TO USE A REAMER TO DECOMPRESS THE BONE AND COMPLETE CASE.

  Patient problems: Insufficient Information

  MAUDE report 13471766 ↗