PINNACLE 2217-00-052Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE ALTER BEARING EXTRACTOR BODY 52mm · Class 1
All models of PINNACLE (182)
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 10603295097280), received between Jul 24, 2018 and Nov 9, 2023 — 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
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS DAMAGED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18100969 ↗MalfunctionJul 30, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE AB EXTRACTION WAS MISSING A TOOTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12252340 ↗MalfunctionMay 24, 2019Device-Device Incompatibility; Device-Device Incompatibility
EXTRACTOR DEFICIENCY IS THAT THE LEVER DOESN¿T HOLD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8640297 ↗MalfunctionJul 24, 2018Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
THERE WAS A 30-MINUTE SURGICAL DELAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7714504 ↗
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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