PINNACLE GRIPTION TF 2217-01-510Recalls & reported problems
Depuy (Ireland) · PINNACLE GRIPTION TF AUGMENT INSTRUMENT CASE · 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 10603295097907), received between Oct 12, 2018 and Jul 7, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (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
- Peeled/Delaminated2
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.
MalfunctionJul 7, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INSTRUMENT BOXES WERE A BIT GRAY AFTER ALL THE CLEANING DONE BEFORE. NOW THEY WASHED THEM FOR THE FIRST TIME IN TRELLEBORG AND THE PAINT (BLACK) CAME OFF ON ALL OTHER INSTRUMENTS THAT WERE IN THE DISHWASHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12129574 ↗MalfunctionOct 12, 2018Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY WAS DELAMINATING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7960753 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
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- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- Calibrate CLCCXSIMPAAlphatec Spine, Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501A2Karl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 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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