PINNACLE 2217-50-004Recalls & reported problems
Depuy (Ireland) · PINNACLE POLY IMPACTOR TIP 22.225mm · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295098935), received between May 26, 2020 and Jul 18, 2025 — classified as 4 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
- Material Twisted/Bent2
Patient problems
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2025Break; Break
IT WAS REPORTED THAT DURING THE SURGERY, THE UPPER PART OF THE ACETABULAR IMPACTING HANDLE BROKE DURING IMPACTION. THIS DID NOT CAUSE ANY DISRUPTION TO THE SURGERY OR TO THE PATIENT, AS IT OCCURRED DURING THE LAST USE OF THIS INSTRUMENT AND WAS NOT NECESSARY FOR FURTHER STEPS IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22544246 ↗MalfunctionJun 26, 2024Break; Break
IT WAS REPORTED, THAT THE PLASTIC WAS BROKEN. IT WAS UNKNOWN, WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19618421 ↗MalfunctionNov 2, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE IMPACTOR TIP WAS CROSS THREADED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10774724 ↗MalfunctionMay 26, 2020Material Twisted/Bent; Material Twisted/Bent
MDR STAFF HAVE NOTICED THE PINNACLE CUP IMPACTOR TIP (221750004) IS CROSS THREADED AND NO LONGER USABLE FOR SURGERY. ITEM WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT DIRECT TO THE FOLLOWING ADDRESS:
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10088289 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 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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