Arthrex® ABS-10062Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867083998), received between Aug 3, 2016 and Nov 8, 2016 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2016Break; Failure to Advance

  IT WAS REPORTED THAT DURING A BMC AND OA/HTO PROCEDURE, THE OPERATING SURGEON ATTEMPTED TO USE THE TROCAR FROM THE KIT IN THE OSTEOTOMY THAT WAS MADE FOR THE HTO BUT THE DRAW WAS UNSUCCESSFUL DUE TO THE OPEN SYSTEM CREATED FROM THE OSTEOTOMY. NEXT THE OPERATING SURGEON MALLETED THE TROCAR INTO THE TIBIAL CREST ABOUT 6 INCHES DISTAL TO THE OSTEOTOMY AND ATTEMPTED A BMC DRAW FROM THAT SITE, WHICH WAS UNSUCCESSFUL. THE SURGEON AND THE SALES REP DISCUSSED THE INCIDENT AND AFTER DISCUSSING WITH A FELLOW SURGEON THEY DETERMINED THAT THEY WOULD TRY TO DRAW VIA THE NOTCH IN THE DISTAL FEMUR. THE TROCAR WAS PLACED IN POSITION AND WAS HIT WITH THE MALLET AND IT ENTERED THE IM CANNULA. THE TROCAR WAS MET WITH SOME RESISTANCE AND THE SURGEON STOPPED IMMEDIATELY. FLUORO WAS UTILIZED TO CONFIRM POSITIONING. THE SURGEON ATTEMPTED ANOTHER DRAW USING THE VACUUM SYRINGES IN THE KITS. THIS ATTEMPT WAS UNSUCCESSFUL AND SURGEON PULLED THE TROCAR OUT OF THE FEMUR. WHEN TROCAR WAS REMOVED THE FELLOW SURGEON REALIZED THAT THE TROCAR TIP WAS BROKEN. THE TIP WAS LODGED IN THE DISTAL FEMUR OF THE PATIENT. FLOURO WAS USED TO TRY AND RECOVER THE TIP BUT WAS UNSUCCESSFUL. PER THE SALES REP, THE OPERATING SURGEO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6085144 ↗
• InjuryOct 18, 2016Break; Component Falling; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE ARTHREX ANGEL BMC KIT WAS BEING USED IN A BMA HARVEST OF THE PROXIMAL TIBIA. ADVANCING THE NEEDLE WITH A MALLET THROUGH THE TIBIA WAS REPORTED TO BE DIFFICULT. IT WAS ALSO DIFFICULT TO TAKE THE TROCAR OUT AFTER ADVANCING THE NEEDLE, ALTHOUGH IT WAS EASY TO PULL BACK THE BMA. WHEN FINALLY ATTEMPTING TO PULL OUT THE NEEDLE, THE DISTAL INCH OF THE NEEDLE WITHOUT TROCAR BROKE-OFF AND WAS LEFT IN THE PROXIMAL TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6037746 ↗
• InjuryAug 3, 2016Break

  IT WAS REPORTED THAT TWO ARTHREX ANGEL BONE MARROW PROCESSING KIT WERE BEING USED FOR A BONE MARROW ASPIRATE CONCENTRATE, PROXIMAL TIBIA PROCEDURE. FOR THE FIRST ATTEMPT TO RETRIEVE BMI FROM THE PATIENT, THE JAMSHIDI NEEDLE TROCAR AND STYLET FUSED TOGETHER UPON INSERTION (LOT NUMBER 526658998). THE SURGEON WAS ABLE TO RETRIEVE THE STYLET FROM THE PROXIMAL TIBIA USING PLIERS. A SECOND ARTHREX ANGEL BONE MARROW PROCESSING KIT WAS OPENED (LOT NUMBER 61186428) AND THE JAMSHIDI NEEDLE BROKE OFF IN THE PATIENT'S TIBIA UPON REMOVAL. THE SURGEON WAS ABLE TO FULLY RETRIEVE THE BROKEN PIECE FROM THE PATIENT BY CREATING A LARGER INCISION (SURGICAL INTERVENTION) TO FULLY RETRIEVE THE BROKEN NEEDLE TIP. THE PATIENT RECEIVED STITCHES TO CLOSE UP THE INCISION. THE BMA WAS SUCCESSFULLY COLLECTED AND SPUN TO FINISH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5843872 ↗