Arthrex® AR-7720-2.0Recalls & reported problems
Arthrex, Inc. · HUMERAL DRILL, 2.0 MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867042124), received between Dec 28, 2020 and Aug 14, 2025 — classified as 1 injury, 7 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.
Reports received per month
Most reported problems
Device problems
- Break8
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
- Foreign Body In Patient1
- Unspecified Tissue Injury1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06990369 THAT AN AR-7720-2.0 HUMERAL DRILL BROKE OFF DURING CASE IN PATIENT ELBOW. HAD TO DEVIATE FROM STANDARD PROCEDURE TO REMOVE THE DRILL PIECE FROM THE MEDIAL EPICONDYLE. THIS OCCURRED DURING USE IN A CASE. THE CASE WAS COMPLETED AFTER REMOVING THE DRILL.
Patient problems: Insufficient Information
MAUDE report 22803591 ↗MalfunctionJun 17, 2025Break; Break
ON 05/23/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7720-2.0 HUMERAL DRILL BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236402 ↗MalfunctionMar 20, 2025Break; Break
IT WAS REPORTED THAT DURING AN UCL STABILIZATION SURGERY THE DRILL BROKE INTO TWO PIECES. THE REPORTED ISSUE WAS INITIALLY IDENTIFIED DURING THE INCOMING INSPECTION AT THE ARTHREX WAREHOUSE. FURTHER INFORMATION WERE REQUESTED AND THE CUSTOMER CONFIRMED THAT THE REPORTED ISSUE HAS OCCURRED DURING A SURGERY BUT DID NOT FORWARD A COMPLAINT AS THE SURGERY COULD BE FINISHED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 21651682 ↗MalfunctionJun 25, 2024Break; Break
ON 5/31/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7720-2.0 HUMERAL DRILL (FROM A LOANER SET RAR-7700S-IN, (B)(6)) BROKE OFF IN THE HUMERAL EPICONDYLE. THE BROKEN PIECE WAS VISIBLE AND EASILY RETRIEVED WITH NO CASE DELAY. IT WAS STATED THAT THE DRILL WAS OSCILLATED WHICH COULD HAVE CONTRIBUTED TO BREAKAGE OF THE DRILL BIT. THE CASE WAS CONTINUED UTILIZING THE 3.5 MM DRILL BIT, AND IT WAS COMPLETED WITH NO ISSUES. THIS WAS DISCOVERED DURING AN ELBOW UCL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19606680 ↗MalfunctionApr 17, 2023Break; Break
IT WAS REPORTED ON (B)(6) 2023 , BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-7720-2.0 HUMERAL DRILL BROKE. CASE INVOLVEMENT, DEVICE BREAKS DURING USE. PER FACILITY: "THE ARTHREX ARTICULATING GUIDE FOR THE 2.5 MM DRILL WAS THEN POSITIONED AND 2 DRILL HOLES WERE CONNECTED WITH THE 15 MM TUNNEL TO CREATE A Y CONFIGURATION FOR DOCKING. THE TENDON AND ALLOWING PASSING SUTURES TO BE TIED OVER A BONE BRIDGE. OF NOTE, DURING DRILLING OF ONE OF THE 2.5 MM TUNNELS, THE DRILL BIT BROKE IN BONE. THE DRILL BIT WAS SUCCESSFULLY REMOVED WITH A HEMOSTAT AND THE MINI C-ARM WAS BROUGHT IN TO CONFIRM THE REMOVAL OF THE METAL BIT. THERE WAS NO SUITABLE BACKUP DRILL BIT IN THE ARTHREX SET SO A 2 MM DRILL BIT WAS OPENED FROM ANOTHER SET AND USED TO REDRILL THROUGH THE GUIDE TO THE BACKSTOP TO COMPLETE THE ANTERIOR Y CONNECTING TUNNEL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16751785 ↗MalfunctionMar 22, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7720-2.0 HUMERAL DRILL BROKE IN THE PATIENT'S BONE DURING THE FIRST DRILLING CYCLE TO PREPARE THE HUMERAL SOCKET. THE BROKEN PIECE WAS DUG OUT OF THE PATIENT'S HUMERUS AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A UCLR PROCEDURE ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 16589535 ↗MalfunctionDec 5, 2022Break
IT WAS REPORTED THAT DURING AN UCL SURGERY THE DRILL TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD-PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DRILL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914088 ↗InjuryDec 28, 2020Break
IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5097977) THAT AN ARTHREX DRILL BIT (AR-7720-2.0, LOT UNKNOWN) BROKE OFF IN THE PATIENT'S LEFT HUMERUS BONE. THE DRILL BIT PIECE WAS TOO SMALL TO REMOVE WITHOUT CAUSING DAMAGE. ADDITIONAL INFORMATION OBTAINED 12/15/20: THE PROCEDURE WAS A LEFT ELBOW ULNAR COLLATERAL LIGAMENT REPAIR, ULNAR NERVE NEUROPLASTY, WITH TENDON GRAFT FROM RIGHT KNEE. DRILL BIT LOT NUMBER UNKNOWN. THE PIECE OF DRILL BIT WAS LEFT IN BECAUSE IT COULD NOT BE RETRIEVED WITHOUT CAUSING DAMAGE. NO UNPLANNED OR LARGER INCISIONS WERE NEEDED AND THE SURGEON DID NOT HAVE TO CHANGE THE PLANNED SURGICAL TECHNIQUE. PROCEDURE WAS COMPLETED AS PLANNED. DEVICE IS NOT AVAILABLE TO RETURN FOR EVALUATION. FACILITY INDICATED IT MAY HAVE BEEN DISCARDED AFTER THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 11075963 ↗
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- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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