PINNACLE 2217-00-048Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE ALTER BEARING EXTRACTOR BODY 48mm · Class 1
All models of PINNACLE (182)
Data updated Oct 16, 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 10603295097266), received between Oct 18, 2019 and Nov 20, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Entrapment of Device1
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE PINNACLE EXTRACTION SET WAS USED TODAY, AND IT LOOKS AS THOUGH A COUPLE OF THE ITEMS ARE BROKEN. THE FEET ARE MISSING.
Patient problems: Insufficient Information
MAUDE report 18169359 ↗MalfunctionOct 18, 2019Break; Entrapment of Device; Material Twisted/Bent; Break; Entrapment of Device; Material Twisted/Bent
IT WAS REPORTED THAT ONE OF THE TEETH BROKE OFF OF THE METAL LINER EXTRACTOR TIP SIZE 48. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9208185 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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