NA 357.365Recalls & reported problems
Synthes GmbH · 125 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS · Class 1
Data updated Oct 13, 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 10886982196002), received between Jul 12, 2019 and Jul 31, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility2
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2020Device-Device Incompatibility; Device-Device Incompatibility
CONCOMITANT DEVICE: UNKNOWN NAIL (PART NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN; QUANTITY: 1).
Patient problems: No Patient Involvement
MAUDE report 10351093 ↗MalfunctionJul 12, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2019, DURING A HIP SURGERY, AN OUTER SLEEVE OF TRIPLE TROCAR FOR DISTAL LOCKING SCREW GOT STUCK ON AN AIMING ARM. COULD NOT DISENGAGE EVEN AFTER THE CASE. INSERTED SCREW THROUGH OUTER SLEEVE AND THEN REMOVED INSERTER HANDLE AND AIMING ARM. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN TROCAR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN DRILL SLEEVE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 125 DEGREE AIMING ARM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8785022 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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