NA 324.084Recalls & reported problems
Synthes GmbH · 1.25MM K-WIRE INSERT · Class 1
Data updated Oct 16, 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 10886982191113), received between Jun 9, 2020 and Jan 10, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Material Twisted/Bent1
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.
MalfunctionJan 10, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, PRIOR TO AN UNKNOWN PROCEDURE, IT WAS NOTICED THAT A SLEEVE WAS DAMAGED. AS THE SURGICAL NURSE TRIED TO FORCEFULLY PASS A WIRE, IT WAS BOUND UP AND COLD WELDED TO THE SLEEVE. THERE WAS NO PATIENT IMPACT SINCE THIS WAS PRIOR TO THE SURGERY. CONCOMITANT DEVICE REPORTED: UNK - CABLE/WIRE: TRAUMA: (PART# UNKNOWN; LOT# UNKNOWN; QUALITY:1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 1.25MM K-WIRE INSERT THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13204964 ↗MalfunctionJun 9, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, WHILE THE SURGEON ATTEMPTED TO PLACE A KIRSCHNER WIRE THROUGH THE KIRSCHNER WIRE INSERT WITHIN THE THREADED DRILL GUIDE, THE KIRSCHNER WIRE WAS UNABLE TO PASS THROUGH THE GUIDE. AFTER THE CASE, THE DEVICE WAS INSPECTED, AND IT WAS DISCOVERED THE KIRSCHNER WIRE INSERT WAS BENT AND WAS NO LONGER USABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN KIRSCHNER WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN DRILL GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10133394 ↗
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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