NA 03.010.082Recalls & reported problems
Synthes GmbH · 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM · Class 1
Data updated Oct 16, 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 10886982067524), received between Oct 18, 2019 and Mar 27, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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
- Device-Device Incompatibility5
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2024Device-Device Incompatibility; Device-Device Incompatibility
SURGEON WAS UNABLE TO PASS A 3.2MM GUIDEWIRE THROUGH THE GUIDEWIRE SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION WAS PROVIDED AT THE TIME. THIS REPORT IS FOR ONE 13.0/3.2 WIRE GUIDE SPIRAL BLD AIM ARM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986403 ↗MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 15/13 F/SPIRAL BLADE-LOCK PROTECT SLEEVE AND A 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM WERE DAMAGED UPON INSPECTION OF INSTRUMENTS PRIOR TO SURGERY. THE SLEEVE WAS STATED TO NOT FIT THROUGH THE JIG EASILY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PROTECT SLEEVE 15/13 F/SPIRAL BLADE-LOCK. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14192974 ↗MalfunctionApr 12, 2021Device-Device Incompatibility; Device-Device Incompatibility
THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11648392 ↗MalfunctionJun 4, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS ALSO REPORTED THAT THERE WAS SURGICAL DELAY OF ONE (1) MINUTE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REMOVING THE WIRE AND REINSERTING OUTSIDE THE LEG BEFORE RE-ENGAGING THE WIRE GUIDE ONTO THE INSERTION HANDLE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Patient Involvement
MAUDE report 10121686 ↗MalfunctionOct 18, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CORRECT GUIDE WIRE FOR SPIRAL BLADE AIMING ARM WOULD NOT FIT THROUGH THE PROTECTION DRILL SLEEVE. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE SURGICAL INVOLVEMENT. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9208436 ↗
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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