Orthopediatrics Instrumentation 01-1501-0128Recalls & reported problems
Orthopediatrics Corp. · Child Nail Conical Extraction Adaptor · Class 1
Data updated Oct 18, 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 00841132177624), received between Dec 5, 2022 and Jan 11, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture4
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2023Fracture; Fracture
BROKEN 4.5 MM HALF PIN APPEARS TO HAVE BROKEN AT THE THREAD/SHAFT JUNCTION OF THE NEAR CORTEX.
Patient problems: Insufficient Information
MAUDE report 16138748 ↗MalfunctionJan 11, 2023Fracture; Fracture
MalfunctionJan 3, 2023Fracture; Fracture
WHILE EXPLANTING THE PEDINAILS THE PROXIMAL SEGMENT BROKE OFF, LEAVING THE REST OF THE NAIL IN THE PATIENT, CONICAL EXTRACTOR WAS SEATED CORRECTLY, THEN THE PROXIMAL GREATER TO LESSER SCREW WAS REMOVED, THEN THE DISTAL LATERAL TO MEDIAL SCREW WAS REMOVED, THEN DURING BACK SLAPPING THE PROXIMAL SEGMENT BROKE OFF AND STAYED ON THE CONICAL EXTRACTOR WHILE THE REST OF THE NAIL WAS IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16090964 ↗MalfunctionDec 5, 2022Fracture; Fracture
BOLT TIP BROKE OFF IN NAIL WHILE TRYING TO EXTRACT NAIL CAUSING A DELAY GREATER THAN 30 MINS.
Patient problems: Insufficient Information
MAUDE report 15921661 ↗
Other BIT, SURGICAL devices
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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