NA 2217-50-090Recalls & reported problems
Depuy (Ireland) · PINNACLE DUAL MOBILITY HEAD TRIAL INSERTION TOOL · Class 1
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 10603295520610), received between Feb 7, 2022 and Apr 23, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility4
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DM HEAD TRIAL INSERTION TOOL IS GETTING STUCK IN THE TRIAL HEADS. ALSO THE SMALL CALCAR PLANAR WILL NOT ATTACH TO THE POWER ADAPTER.
Patient problems: Insufficient Information
MAUDE report 19162437 ↗MalfunctionJun 20, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT A PINNACLE MB HEAD TRIAL 47/28 IS STUCK ON THE DM HEAD TRIAL INSSERTION TOOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17164220 ↗MalfunctionJun 16, 2023Break; Break
IT WAS REPORTED THAT THE HANDLE WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17143934 ↗MalfunctionJul 26, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DUAL MOBILITY FEMORAL HANDLE STUCK INSIDE TRAIL POLY SHELL. CANNOT GET APART. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15104359 ↗MalfunctionFeb 7, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED HANDLE STUCK IN HEAD TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13469704 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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