DJO SURGICAL 803-15-008Recalls & reported problems
Encore Medical, L.P. · Drill Bit, 3.2x35mm, Bayonet · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446289265), received between Feb 27, 2020 and Jul 16, 2025 — classified as 2 injuries, 5 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Therapeutic or Diagnostic Output Failure2
- Adverse Event Without Identified Device or Use Problem1
- Deformation Due to Compressive Stress1
- Detachment of Device or Device Component1
- Material Integrity Problem1
- Mechanical Problem1
- No Apparent Adverse Event1
Patient problems
- Foreign Body In Patient5
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
INSTRUMENT FAILURE - DRILL BIT BROKE, BROKEN FRAGMENTED PIECES LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22527196 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INSTRUMENT FAILURE - DRILL BITS BROKE WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066790 ↗MalfunctionMar 7, 2025
DJO SURGICAL BAYONET DRILL BIT (PART #803-15-008). AT TIME OF SURGICAL PREPARATION FOR CANCELLOUS BONE SCREW DURING A TOTAL HIP ARTHROPLASTY PROCEDURE, DURING NORMAL USE OF THE DRILL, THE BIT BROKE OFF WHILE INSIDE THE PATIENT. PER SURGEON, MULTIPLE ATTEMPTS TO REMOVE THE BROKEN DRILL BIT WERE UNSUCCESSFUL. HE JUDGED FURTHER ATTEMPTS TO REMOVE THE RETAINED RILL BIT AS HAVING THE POTENTIAL FOR SIGNIFICANT DAMAGE TO THE BONE AND DECIDED TO PROCEED WITH THE SURGERY, LEAVING THE RETAINED DRILL BIT IN PLACE. THE RECOVERED PORTION OF THE DRILL BIT WAS MEASURED AT 15MM. SURGEON THEN ESTIMATED THE LENGTH OF THE RETAINED PORTION OF THE DRILL BIT AT 20MM. SURGEON ANTICIPATES NO EFFECTS TO PATIENT OF RETAINED PIECE.
Patient problems: Foreign Body In Patient
MAUDE report 21546341 ↗MalfunctionJun 18, 2024Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem
INSTRUMENT FAILURE - INSTRUMENT BROKE, PIECE LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19555569 ↗MalfunctionApr 8, 2024No Apparent Adverse Event; No Apparent Adverse Event
INSTRUMENT FAILURE - INSTRUMENT BROKE, PIECELEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19068592 ↗MalfunctionMay 25, 2022Break; Therapeutic or Diagnostic Output Failure
INSTRUMENT FAILURE - ITEM BROKE DURING THE CASE/TIP WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 14493453 ↗MalfunctionFeb 27, 2020Break; Therapeutic or Diagnostic Output Failure
INSTRUMENT FAILURE - DURING SURGERY BOTH DRILL BITS SNAPPED WHEN THE SURGEON WAS DRILLING INTO THE CUP FOR SCREWS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9764226 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page