PULLUP Drill bitRecalls & reported problems
S.B.M · PULLUP® Ø 4.5 mm cannulated drill bit, to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruction. · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03760154006163), received between Oct 10, 2024 and Jun 11, 2025 — classified as 2 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient2
- Insufficient Information2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2025Break; Break
(B)(4). INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "A 4.5MM DRILL BIT BROKE AGAIN ON TUESDAY IN THE (B)(6) CLINIC'S OPERATING ROOM".
Patient problems: Insufficient Information
MAUDE report 22182393 ↗InjuryFeb 21, 2025Break; Break
FNCONF-25-0031 INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "DURING THE LIGAMENTOPLASTY PROCEDURE, THE 4.5MM DIAMETER CANNULATED DRILL (REF. (B)(6) BROKE IN THE PATIENT'S KNEE, WITH MANY PIECES OF METAL TO BE RECOVERED FROM THE PATIENT'S KNEE JOINT. THE INSTRUMENT BROKE LENGTHWISE. THIS INCIDENT SIGNIFICANTLY INCREASED SURGERY TIME".
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 21431608 ↗MalfunctionOct 10, 2024Break; Break
(B)(4). INCIDENT OCCURED IN MALAISIA. EVENT DESCRIPTION COMMUNICATED. "WE WOULD LIKE TO INFORM THAT OUR ORDER FOR ITEM CANNULATED DRILL BIT Ø 4.5 MM (PULL000255) IS BECAUSE THE ITEM IS BROKEN FROM THE POST SURGERY ACL RECON PROCEDURE. THE ITEM THAT WAS USED AT THAT TIME IS PULL000255, WITH LOT NUMBER 221735. PLEASE FIND ATTACHED THE ITEM PHOTOS FOR REFERENCE. THIS ITEM IS ALSO FREQUENTLY USED AND VERY NEEDED ON THE ACL/PCL RECONSTRUCTION PROCEDURE".
Patient problems: Foreign Body In Patient
MAUDE report 20417439 ↗
Other Bit, Drill devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.