Titan Modular Shoulder System 2.5 DRS-0926-001Recalls & reported problems
Smith & Nephew, Inc. · 2.8MM GLENOID DRILL SHAFT · Class 1
All models of Titan Modular Shoulder System 2.5 (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556860236), received between Dec 26, 2023 and Feb 24, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Fracture
IT WAS REPORTED THAT, DURING A REVERSE TSA SURGERY, THE TIP OF ONE (1) 2.8 MM GLENOID DRILL SHAFT WAS BROKEN AND WOULD NOT ALLOW ATTACHMENTS TO STAY ON. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430042 ↗MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER, USING THE PERIPHERAL BASEPLATE REAMER, THE DOCTOR NOTICED SOMETHING OFF WITH THE DRIVER WHILE SPINNING, PULLED IT OUT OF THE JOINT AND THE SPRING AND COLLAR INSIDE THE 2.8MM GLENOID DRILL SHAFT FELL OUT ON THE FLOOR. THE ATTACHMENT WAS STILL IN THE T-HANDLE AND CAUGHT THE OUTER BLACK SHAFT. NOTHING FELL INSIDE THE PATIENT; IT WAS CONFIRMED WITH X-RAYS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, BY USING A RONJOUR. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23900408 ↗MalfunctionDec 2, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE CONNECTION PIECE OF ONE (1) 2.8MM GLENOID DRILL SHAFT CRACKED WHILE USING IT INSIDE PATIENT. THERE WAS 2 PIECES THAT WERE RETRIEVED USING TWEEZERS INSIDE THE PATIENT. EVERYTHING WAS RETRIEVED AND TAKEN OUT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693378 ↗MalfunctionMay 2, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE OF THE FLANGES BROKE OFF ON THE TIP OF ONE (1) 2.8MM GLENOID DRILL SHAFT. THEY WERE ALL RETRIEVED, NOTHING WAS LEFT INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950571 ↗MalfunctionDec 26, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, DOCTOR WAS USING A 2.8MM GLENOID DRILL SHAFT WITH A GLENOID REAMER EXTRA SMALL TO REAM THE SURFACE OF THE GLENOID. THE REAMER WAS CATCHING ON THE RETRACTORS THAT THEY HAD IN PLACE WHICH BROKE THE TIP OF THE DRILL SHAFT THAT CAPTURES THE REAMER. TWO SMALL PIECES OF METAL WERE REMOVED FROM THE SHOULDER WHICH THE SURGEON CONFIRMED WERE THE ONLY BROKEN PIECES OF METAL IN THE SHOULDER. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18395392 ↗
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.
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