RELIANCE AL 48361235Recalls & reported problems
Stryker Corporation · RASP HANDLE · Class 1
All models of RELIANCE AL (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327269116), received between Nov 4, 2016 and Jul 19, 2022 — classified as 5 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 Component1
- Detachment of Device or Device Component1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2022Fracture; Fracture
IT WAS REPORTED THAT A RELIANCE SLIDE RASP HANDLE TIP BROKE OFF WITHIN A RELIANCE SLIDE RASP TRIAL INTRA-OPERATIVELY. THE RASP WAS SUCCESSFULLY REMOVED, AN ALTERNATE DEVICE WAS USED AND SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15053524 ↗MalfunctionNov 20, 2018Fracture; Break; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON GOING TO REMOVE THE TRIAL AND INSERTER THE INSERTER CAME OUT WITHOUT TRIAL ATTACHED. IT WAS OBSERVED THAT THE THREADS HAD BROKEN OFF THE INSERTER. THE SECOND INSERTER WAS THAN USED AND SCREWED INTO THE TRIAL AND REMOVED SUCCESSFULLY WITHOUT DELAY OR ISSUE. SURGEON BELIEVED THAT HE DID NOT FULLY SCREW IN THE INSERTER UPON REATTACHING IT TO THE TRIAL WHILE IN-SITU. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO PATIENT ADVERSE CONSEQUENCE WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8093345 ↗MalfunctionMay 31, 2018Break; Fracture; Fracture
IT WAS REPORTED THE TRIAL DISTAL TIP BROKE. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7557627 ↗MalfunctionNov 8, 2017Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE TRIAL HANDLE BROKE DURING IMPACTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7012202 ↗MalfunctionNov 4, 2016Break; Detachment Of Device Component
IT WAS REPORTED THAT; TRIAL HANDLE BROKE OFF IN ALIF TRIAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6080558 ↗
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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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