NA 2218-90-000Recalls & reported problems
Depuy (Ireland) · AB STRAIGHT INSERTER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295102175), received between Dec 30, 2021 and Apr 25, 2023 — classified as 2 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
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2023Break; Break
IT WAS REPORTED THAT WHILE IMPLANTING PINNACLE CUP, THE TIP WAS BROKEN OFF FROM THE CUP INSERTER. THE SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806325 ↗MalfunctionDec 30, 2021Break; Break
QUESTIONS: 1. PLEASE PROVIDE PRODUCT AND LOT CODES OF THE UNK INSTRUMENT REPORTED AS 2ND IP? 2. LOT NUMBER OF AB STRAIGHT INSERTER (PRODUCT CODE: 221890000). 3. WHAT PART OF THE INSTRUMENT BROKE? 4. DID IT BREAK INTO TWO OR MORE PIECES? 5. WERE ALL PIECES RETRIEVED FROM THE PATIENT? 6. DID INSTRUMENT USED DURING SURGERY? IF YES, WAS SURGERY TIME EXTENDED? 7. IF YES, WHAT IS THE DURATION OF THE DELAY? 8. EVENT DATE. APOLOGIES, BUT THESE ITEMS HAVE ALREADY BEEN REMOVED FROM SETS AND RETURNED. BELOW ARE THE FEW DETAILS WE REMEMBER ABOUT THE INSERTER BUT NO FURTHER DETAILS AVAILABLE. ANSWERS: 1) GRIPPER LOT NUMBER: NOT AVAILABLE. 2) AB STRAIGHT INSERTER LOT NUMBER: NOT AVAILABLE. 3) END OF THE IMPACTOR CAME OFF. GRIPPER FAULT UNKNOWN. 4) STRAIGHT INSERTER NOW IN 2 PARTS. GRIPPER CONDITION UNKNOWN. 5) NEITHER OCCURRED OVER PATIENT. 6) UNKNOWN. 7) UNKNOWN. 8) BOTH FOUND TO BE BROKEN ON (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13118840 ↗
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- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
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- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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