MICA 57S02025Recalls & reported problems
Wright Medical Technology, Inc. · Hex Driver · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889797056717), received between Apr 11, 2024 and Apr 11, 2024 — classified as 2 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Material Fragmentation2
Patient problems
- Foreign Body In Patient2
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2024Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation
IT WAS REPORTED THAT THE STERILE PACKED MICA 2.5 HEX DRIVERS SHATTERED INSIDE PATIENT WHILE ATTEMPTING TO REMOVE A SCREW. TWO DRIVERS BROKE AND STRIPPED THE THREADS INSIDE OF SCREW HEAD, A 3RD DRIVER WAS USED TO ADVANCE A SEPARATE SCREW FORWARD WITH NO ISSUES. THE PATIENT WAS BOOKED FOR REMOVAL OF HARDWARE, HARDWARE WAS UNABLE TO BE REMOVED AND IS STILL IMPINGING UPON SOFT TISSUES. INCISION SITE WAS OPENED SIGNIFICANTLY AND BONE AROUND IMPLANT WAS CARVED OUT IN ATTEMPT TO RETRIEVE HEAD WITH NO SUCCESS. CASE LASTED MUCH LONGER THAN ANTICIPATED DUE TO THESE ISSUES.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19086078 ↗InjuryApr 11, 2024Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation
IT WAS REPORTED THAT THE STERILE PACKED MICA 2.5 HEX DRIVERS SHATTERED INSIDE PATIENT WHILE ATTEMPTING TO REMOVE A SCREW. TWO DRIVERS BROKE AND STRIPPED THE THREADS INSIDE OF SCREW HEAD, A 3RD DRIVER WAS USED TO ADVANCE A SEPARATE SCREW FORWARD WITH NO ISSUES. THE PATIENT WAS BOOKED FOR REMOVAL OF HARDWARE, HARDWARE WAS UNABLE TO BE REMOVED AND IS STILL IMPINGING UPON SOFT TISSUES. INCISION SITE WAS OPENED SIGNIFICANTLY AND BONE AROUND IMPLANT WAS CARVED OUT IN ATTEMPT TO RETRIEVE HEAD WITH NO SUCCESS. CASE LASTED MUCH LONGER THAN ANTICIPATED DUE TO THESE ISSUES.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19086077 ↗
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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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