REFLEX HYBRID 48511905Recalls & reported problems
Stryker Corporation · SCREW EXTRACTOR · Class 1
All models of REFLEX HYBRID (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327270952), received between Jul 5, 2016 and Apr 6, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Most reported problems
Device problems
- Break4
- Fracture3
- Detachment Of Device Component2
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2018Fracture; Break; Detachment Of Device Component; Fracture
IT WAS REPORTED THAT THE SURGEON WAS TRYING TO BACK OUT AND REPOSITION A SCREW AND THE TIP OF THE INNER DRAW ROD SNAPPED OFF WITHIN THE SCREW. ALL BROKEN FRAGMENTS WERE RETRIEVED AND THERE ARE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7402137 ↗MalfunctionApr 6, 2018Fracture; Break; Detachment Of Device Component; Fracture
IT WAS REPORTED THAT THE SURGEON WAS TRYING TO BACK OUT AND REPOSITION A SCREW AND THE TIP OF THE INNER DRAW ROD SNAPPED OFF WITHIN THE SCREW. ALL BROKEN FRAGMENTS WERE RETRIEVED AND THERE ARE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7402135 ↗MalfunctionJul 7, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; THE INNER SHAFT OF THE EXTRACTION SCREWDRIVER BROKE DURING A CASE. I WAS NOT IN CASE AS IT WAS JUST A REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6694615 ↗MalfunctionJul 5, 2016Break
IT WAS REPORTED THAT; DURING EXTRACTION SURGERY OF, THE TIP OF THE EXTRACTOR INNER SHAFT BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5769457 ↗
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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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