NA 03.816.004Recalls & reported problems
Synthes GmbH · 3RD BLADE HOLDER · 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 10705034730653), received between Jul 18, 2019 and Oct 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (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
- Compatibility Problem1
- Device Difficult to Maintain1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2024Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT DURING LOCAL/INTERNAL INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT ON (B)(6) 2024, IT WAS IDENTIFIED THAT THE BLADE HOLDER COULD NOT HOLD THE LETTER. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A 3RD BLADE HOLDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427497 ↗MalfunctionNov 7, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BLADES OF THE INSIGHT LATERAL RETRACTOR EVALUATION SET WERE NOT FUNCTIONAL AND DOES NOT LOAD INTO THE POSTERIOR UNKNOWN BLADE HOLDER. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN BLADE HOLDER ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9291807 ↗MalfunctionJul 18, 2019Device Difficult to Maintain; Device Difficult to Maintain
IT WAS REPORTED ON (B)(6) 2019, DURING AN INSPECTION OF THE LOANER SET, A RETRACTOR BODY AND A 3RD BLADE HOLDER WERE NOT FUNCTIONING CORRECTLY. THE 3RD BLADE HOLDER WAS DISCOVERED NOT ALLOWING THE BLADE TO BE INSERTED FLUSH. THE ISSUE WAS DISCOVERED DURING AN OVERVIEW BEFORE CHECKING THE SET IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8805391 ↗
Other RETRACTOR devices
- Endo Paddle Retract 173046Covidien LP · RETRACTOR56 reports
- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 3104RIntegra Lifesciences Corporation · RETRACTOR1 recall0 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