NA 03.164.017Recalls & reported problems
Synthes GmbH · PLATE HOLDER ANGLED · Class 1
Data updated Oct 16, 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 10886982311030), received between Dec 20, 2023 and May 15, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT PELVIC SURGERY ON (B)(6) 2026. WHILE GOING TO USE IAP ANGLED PLATE HOLDER (FIELD EQUIPMENT SET), 2 (OF 4) PRONGS WERE BROKEN OFF. WAS ABLE TO COMPLETE CASE WITHOUT ANY DISRUPTION, THAT SPECIFIC INSTRUMENT WAS JUST NOT USABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191160 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT THE PLATE HOLDER ANGLED BROKE OFF. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22317814 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CHECKING IN THE INTRA PELVIC SYSTEM IT WAS NOTICED THAT THE PLATE HOLDER WAS BROKEN. OF THE FOUR PIECES THAT MOVE TO HOLD THE PLATE IT APPEARS AT LEAST ONE HAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767707 ↗MalfunctionDec 20, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023 PRIOR TO THE OPERATION, IT WAS DISCOVERED THAT ONE OF THE TABS ON THE PLATE HOLDER IN QUESTION WAS BROKEN. THE PLATE WILL NOT HOLD SECURELY TO THE PLATE HOLDER. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. THIS REPORT IS FOR A PLATE HOLDER ANGLED. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18366123 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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