AGILITY 2555-89-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295142652), received between Sep 10, 2018 and Aug 6, 2025 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT THE 3.2MM DRILL BIT FROM THE DELTA XTEND TRAYS HAD BROKEN AND HAD BEEN DISCARDED AS A RESULT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE. THE ITEM BROKE INTO TWO PIECES AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725075 ↗
• InjuryDec 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ANOTHER OPERATIVE HAS BEEN INJURED BY A POORLY PACKAGED ITEM RECEIVED FROM DEPUY (B)(4). A VERY SHARP DRILL BIT WAS PACKAGED IN A POLYETHYLENE BAG WITH NO PROTECTION ON THE SHARP END. THE DRILL BIT HAS PIERCED THE BAG AND THE OPERATIVE HAD CUT HIMSELF WHEN PICKING OUT THE ITEM FOR AN ORDER.

  Patient problems: Injury

  MAUDE report 8185271 ↗
• InjuryDec 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ANOTHER OPERATIVE HAS BEEN INJURED BY A POORLY PACKAGED ITEM RECEIVED FROM DEPUY, (B)(4). A VERY SHARP DRILL BIT WAS PACKAGED IN A POLYETHYLENE BAG WITH NO PROTECTION ON THE SHARP END. THE DRILL BIT HAS PIERCED THE BAG AND THE OPERATIVE HAD CUT HIMSELF WHEN PICKING OUT THE ITEM FOR AN ORDER.

  Patient problems: Injury

  MAUDE report 8185175 ↗
• InjuryDec 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ANOTHER OPERATIVE HAS BEEN INJURED BY A POORLY PACKAGED ITEM RECEIVED FROM DEPUY, WARSAW. A VERY SHARP DRILL BIT WAS PACKAGED IN A POLYETHYLENE BAG WITH NO PROTECTION ON THE SHARP END. THE DRILL BIT HAS PIERCED THE BAG AND THE OPERATIVE HAD CUT HIMSELF WHEN PICKING OUT THE ITEM FOR AN ORDER.

  Patient problems: Injury

  MAUDE report 8178724 ↗
• MalfunctionOct 4, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THE REPORTED DEVICE WAS USED FOR THE DRILLING WITH 3.2MM DRILL (P/N AND LOT NUMBER WERE UNKNOWN) DURING THE SURGERY (DATE OF THE SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE DRILL WAS STUCK WITH REPORTED CUTTING GUIDE, SO THAT THE DRILL COULD NOT BE COME OFF. THE SURGEON REMOVED THE CUTTING GUIDE TOGETHER WITH STUCK DRILL TO COMPLETE THE SURGERY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933991 ↗
• MalfunctionSep 12, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE REPORTED DRILL COULD NOT DRILL TO FIT THE CUTTING GUIDE TO THE PATIENT¿S BONE DURING ARTIFICIAL SHOULDER JOINT REPLACEMENT SURGERY ON (B)(6) 2018. ALSO, THE DRILL COULD NOT BE DETACHED FROM THE CUTTING GUIDE. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7869264 ↗
• MalfunctionSep 10, 2018Break; Break

  INSTRUMENTS ARE BROKEN AND NEED TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. ONE EACH IMPACTED, ONE EACH NEEDING REPLACEMENT . NO CHARGE REPLACEMENT FOR (B)(4) ON PO (B)(4) (PRONG USED TO REMOVE LINER BROKE OFF) . NO CHARGE REPLACEMENT FOR (B)(4) ON PO (B)(4) (ONLY INFORMATION GIVEN WAS THAT THIS WAS BROKEN AND MISSING FROM THE SET). SOLD TO (B)(4); SHIP TO (B)(4). PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7861521 ↗