Skip to content

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 ↗

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page