TARGETING MODULE TIBIAL NAIL 1238-100Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848665006049), received between Dec 19, 2023 and May 14, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Crack1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2025Crack; Crack
ON 04/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1238-100 TARGETING MODULE JIG CRACKED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22017908 ↗MalfunctionJun 14, 2024Break; Break
ON 05/04/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0837-000 IMPACTOR PAD, AND A 1238-100 TARGETING MODULE BROKE/FAILED. THIS OCCURRED DURING A CASE, THE CASE WAS COMPLETED WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 05/09/2023 WHERE THE SALES REPRESENTATIVE REPORTED THAT THIS EVENT OCCURRED DURING AN IM NAILING OF A TIBIA ON 05/03/2023, WHERE THE IMPACTOR PAD STRIPPED A THREAD NOT ALLOWING IT TO SCREW INTO THE INSERTION HANDLE. THIS HAPPENED EXTERNALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19542307 ↗MalfunctionDec 19, 2023Defective Device; Defective Device
ON 11/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1238-100 TARGETING MODULE BOLT WAS STRIPPPED/CROSS-THREADED AND WASN¿T ABLE TO BE ATTACHED. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18358432 ↗
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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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