Knee Instruments 02.07.10.2303Recalls & reported problems
Medacta International SA · Pin Ø3.2 L=150 ISO5835-L=25-Meche-Triangle · Class 1
All models of Knee Instruments (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040763240), received between Apr 25, 2025 and Sep 11, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Fracture
During a NextAR surgery, the 3.2 x 150 mm Meche-Triangle pin broke while the surgeon was repositioning it. The broken fragment could not be retrieved and was therefore left in situ. A back-up pin was subsequently used to complete the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732102 ↗MalfunctionJan 13, 2026Adverse Event Without Identified Device or Use Problem
DURING REMOVAL, THE PIN FRACTURED, LEAVING THE THREADED PORTION RETAINED IN THE PATIENT. THE SURGEON ASSESSED A RISK OF FRACTURE AND DECIDED TO LEAVE THE FRAGMENT IN SITU. 30 MINUTES OF DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051154 ↗InjuryApr 25, 2025Fracture; Fracture
BROKEN PIN DETECTED IN THE X-RAY POST OPERATION. IT WAS USED FOR FIXATION OF THE NEXTAR CAMERA TO THE CORACOID. THE PATIENT WAS TAKEN BACK TO SURGERY THE DAY AFTER THE PRIMARY TO REMOVE THE PIN.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21908715 ↗
Other Orthopedic Manual Surgical Instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page