RELIANCE ALRecalls & reported problems across all models

We found 5 models of RELIANCE AL by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2016 and Jul 19, 2022 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RELIANCE AL problems

RELIANCE AL models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RELIANCE AL 48361234

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  21 reports
• RELIANCE AL 48361235

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  5 reports
• RELIANCE AL 48361226

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• RELIANCE AL 48361267

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• RELIANCE AL 48366205

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent RELIANCE AL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2022Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  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 TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053527 ↗
• 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 ↗
• MalfunctionSep 21, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TRIAL INSERTER BROKE INSIDE THE TRIAL UPON IMPACTION. THE TIP OF THE INSERTER REMAINED INSIDE THE TRIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898539 ↗
• MalfunctionAug 29, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE THREADED PORTION OF THE SHAFT BROKE OFF WHILE IN PATIENT. TRIAL WAS REMOVED USING A KOCHER. A SURGICAL DELAY OF APPROXIMATELY 1 MINUTE WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7831422 ↗
• MalfunctionJul 2, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT DURING AN L4-5 SURGERY, THE TIP OF THE TRIAL HANDLE BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7656594 ↗
• MalfunctionJun 13, 2018Break; Fracture; Fracture

  IT IS REPORTED THAT A TRIAL INSERTER TIP BROKE UPON IMPACTION. NO DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598024 ↗
• MalfunctionJun 1, 2018Break; Entrapment of Device; Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON REMOVED THE TRIAL HANDLE TO TAKE A COUPLE OF X-RAYS WITH THE TRIAL IN THE DISC SPACE. UPON REINSERTING/RETHREADING THE TRIAL INSERTER INTO THE TRIAL, THE THREADED TIP BROKE OFF INSIDE OF THE TRIAL. THE SURGEON USED A CURETTE FROM THE HOSPITAL TO REMOVE THE TRIAL FROM THE DISC SPACE AND THEN USED A SECOND TRIAL INSERTER TO TRIAL DIFFERENT SIZES FOR THE REST OF THE CASE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7560736 ↗
• 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 ↗
• MalfunctionMar 21, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT A PIECE AT THE TIP OF THE TRIAL INSERTER BROKE OFF INSIDE THE TRIAL, WHILE TESTING FOR SIZE IN THE PATIENT. A BACKUP INSTRUMENTT WAS USED TO REMOVE THE TRIAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7356727 ↗
• MalfunctionDec 28, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; TRIAL THREADS BROKE OFF IN TRIAL.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7150786 ↗
• 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 ↗
• MalfunctionOct 9, 2017Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTRUMENT BROKE. ALTERNATIVE INSTRUMENT WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6932438 ↗
• MalfunctionJul 7, 2017Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHILE I WAS PUTTING SETS BACK TOGETHER TO GO BACK UP FOR A CASE, I NOTICED THAT THE TRIAL HANDLE WAS MISSING ITS TIP AND THERE WAS ALSO A SOLID TRIAL WITH A TIP BROKEN OFF IN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6694608 ↗
• MalfunctionJun 29, 2017Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT;THE TIP OF TWO TRIAL HANDLES BROKE OFF INTO THE TRIALS IN THE CASE. ALL BROKEN FRAGMENTS. REPLACEMENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676665 ↗

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