PINNACLE GRIPTION TF 2217-01-516Recalls & reported problems
Depuy (Ireland) · PINNACLE GRIPTION TF RASPING STRIKE PLATE · 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 10603295097969), received between Jul 23, 2018 and Dec 7, 2020 — 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
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionDec 7, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE STRIKE PLATE AND THE RASPING HANDLE ARE STUCK TOGETHER AND WILL NOT COME APART. THIS DID NOT DELAY SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10961885 ↗MalfunctionJul 23, 2018Break; Break
IT WAS REPORTED THAT THE PINNACLE TF GRIPTION RASPING STRIKE PLATE RELEASE BUTTON IS BROKEN AND CANNOT BE REMOVED FROM THE AUGMENT RASPING HANDLE. THERE WAS NO SURGICAL DELAY APPLICABLE TO THIS CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7709829 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page