Spine Instruments 03.65.10.0038Recalls & reported problems
Medacta International SA · Threaded retractable screwdriver · Class 1
All models of Spine Instruments (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971213395), received between Mar 4, 2020 and Mar 4, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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 18, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device1
Patient problems
- Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2020Device Damaged by Another Device; Device Damaged by Another Device
THE PATIENT RECEIVED AROUND A YEAR AGO A BILATERAL STABILIZATION WITH MUST SI. THE PATIENT HAD STILL PAIN AFTER SURGERY BUT NO CT SCAN OR OTHER DIAGNOSTICS WERE PERFORMED. A NEUROLOGIST SUSPECTED AN L5 NERVE ROOT IRRITATION AND THE PATIENT WAS SENT TO THE SURGEON THAT ORDERED A SPECT/CT WHERE A MISPLACEMENT OF 1 SCREW WAS VISIBLE AS WELL AS THE LOOSENING OF THE SCREWS ON THE OTHER SIDE. SO THE SURGEON DECIDED TO PERFORM REVISION SURGERY, EXPLANTATION OF THE SCREWS AND REINSTRUMENTATION FROM POSTERIOR WITH A PELVIC PLATE AND BILATERAL DECORTICATION OF THE SI JOINT AND PLACEMENT OF AUTOGRAFT (DATE OF PRIMARY IS UNKNOWN). DURING REVISION ALL IMPLANTS WERE SOLIDLY INGROWN IN THE BONE. VERY DIFFICULT TO REMOVE. THE SURGEON TRIED TO REATTACH THE SCREWDRIVER WITH INNER THREAD TO THE SI SCREW IN SITU. THIS WAS IMPOSSIBLE AND DURING HIS ATTEMPT 2 SCREWDRIVERS WERE DAMAGED. THE INNER THREAD WAS BLOCKED INSIDE THE SCREWDRIVERS. THE T HANDLE USED BROKE DUE TO EXCESSIVE FORCE NEEDED. 1 SCREW, THAT WAS CORRECTLY PLACED COULD NOT BE REMOVED, EVEN BY USING THE CONICAL EXTRACTION BOLT IN COMBINATION WITH A FORCEPS. THE TIP OF THE EXTRACTION BOLT BROKE OFF AND THE SURGEON DECIDED TO LEAVE THE SCREW
Patient problems: Irritation
MAUDE report 9785158 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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