Shoulder System Instrument 04.01.10.0284Recalls & reported problems
Medacta International SA · Glenoid polyaxial screwdriver - Non-retentive · Class 1
Data updated Oct 18, 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 07630971211902), received between Jan 17, 2019 and May 28, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Device Fell1
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026No Apparent Adverse Event
AFTER THE SURGERY (WOUND CLOSURE), THE X-RAYS EXAMINATION REVEALED THAT THE TIP OF THE INSTRUMENT HAD BROKEN. THE WOUND WAS REOPENED, AND THE BROKEN FRAGMENT WAS REMOVED. NO FRAGMENTS REMAIN INSIDE THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE TOTAL SURGERY TIME WAS 3.5 HOURS, AND THE DELAY TIME WAS 1.5 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313935 ↗MalfunctionNov 24, 2021Material Integrity Problem; Material Integrity Problem
THE SURGEON HAD DIFFICULTY IMPLANTING THE GLENOSPHERE. LOOKING AT THE X-RAYS, A FRAGMENT OF THE SCREWDRIVER WAS NOTICED. THE SURGEON REMOVED THE FRAGMENT AFTER REMOVING THE IMPLANT. A NEW GLENOSPHERE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 30 MINUTES DELAY, TOTAL SURGERY TIME 130 MINUTES. ALSO, THE GLENOSPHERE SCREW THREAD WAS DEFORMED.
Patient problems: Insufficient Information
MAUDE report 12868652 ↗MalfunctionJan 17, 2019Break; Detachment of Device or Device Component; Device Fell
DURING SURGERY, ONE PIECE OF THE TIP OF THE SCREWDRIVER WAS BROKEN. THE PIECES FELL INTO THE PATIENT AND THEN THE SURGEON RECOVERED ALL THE FRAGMENTS. THE SURGERY WAS COMPLETED WITH THE SAME SCREWDRIVER USING THREE TIPS. NO DELAY WAS REPORTED, THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 8256601 ↗
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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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