screwdriver 264683Recalls & reported problems
Fournitures Hospitalieres Industrie · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03661489646836), received between Dec 14, 2018 and Dec 14, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Accessory Incompatible” (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.
Most reported problems
Device problems
- Accessory Incompatible1
- Compatibility Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2018Accessory Incompatible; Compatibility Problem; Accessory Incompatible; Compatibility Problem
WHILE DOING A REVISION RSA USING CUSTOM IMPLANTS AND V12 INSTRUMENT SET, WE WERE NOT ABLE TO GET THE GLENOSPHERE SCREW TO FULLY ENGAGE WITH METAL BACK GLENOID (SIZE 46 LP). GLENOSPHERE AND FH METAL BACK GLENOID HAD TO BE REMOVED AND REPLACED WITH DJO ENCORE BASEPLATE AND GLENOSPHERE. FH STEM STAYED IN PLACE AND CUSTOM HUMERAL HEAD (B)(4) WAS IMPLANTED ((B)(4)) AFTER THE CASE IT WAS DISCOVERED THAT DUE TO V12 SCREWDRIVER'S TAPERED DESIGN, IT IS IMPOSSIBLE FOR THE SCREWDRIVER TO FULLY GO DOWN SCREW SHAFT ON 44 IMPLANT. NO CONSEQUENCE FOR THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8163616 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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