NA 03.616.036Recalls & reported problems
Synthes GmbH · TISSUE RETRACTOR-END · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034716282), received between Jul 7, 2020 and Aug 5, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING A MATRIX MIS SPINAL CASE. UPON TISSUE RETRACTOR REMOVAL, THE END CLICKS OF THIS INSTRUMENT BROKE. FRAGMENTS WERE GENERATED OUTSIDE OF THE PATIENT FIELD. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-END. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10368448 ↗MalfunctionJul 7, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN MIS MATRIX SPINAL PROCEDURE, THE NURSE ATTEMPTED TO REMOVE THE SHORT RETRACTOR SLEEVE FROM THE UNKNOWN SCREW BECAUSE THEY LOADED THE INCORRECT SCREW SIZE. THE NURSE HAD SOME DIFFICULTY REMOVING THE SLEEVE AND THE INNER PIECE WHICH ATTACHED THE SLEEVE TO THE SCREW CAME OFF. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: SPINE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-END. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10241246 ↗
Other RETRACTOR devices
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- 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.
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