Infinity KGP035Recalls & reported problems
Conmed Corporation · INFINITY 3.5 MM SPADE TIP GUIDE PIN · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854648978), received between Jan 3, 2024 and Jan 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2024Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, KGP035, 3.5MM SPADE TIP GUIDE PIN, WAS IN USE IN AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023, AND, ¿WHEN THEY WERE PERFORMING THE FEMORAL TUNEL, THE TIP OF THE KGP035 BROKE IN THE FIRST CORTICAL, LEAVING THE TIP INTO THE JOINT. THE SURGEON HAD TO REMOVE IT, DELAYING THE SURGERY, AND MAKING THE SITUATION A LITTLE STRESSFUL¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE, WITH A REPORTED DELAY OF 15 MINUTES. THERE IS NO REPORT OF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18438275 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.