BRISTOW LATARJET 285143Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705022533), received between Aug 22, 2018 and Oct 4, 2023 — 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE OF THE SHOULDER ON (B)(6) 2023, IT WAS OBSERVED THAT THE BRISTOW-LATARJET GLENOID 2.9 MM DRILL BIT DEVICE BROKE WHILE TRYING TO DRILL A HOLE IN THE GLENOID. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WAS A 45 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870888 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A LATARJET PROCEDURE THEIR BRISTOW LATARJET GLENOID 2.9MM DRILL BIT BROKE IN HALF. THE BROKEN PIECE WITH REMOVED FROM THE PATIENT WITH NO ISSUE OR DEBRIS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A FIVE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS AN OLDER DEVICE AND HAS SEEN HEAVY USE IN THE FIELD. THE ONE HALF OF THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9448658 ↗
• MalfunctionJan 17, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE DISTAL TIP ON THE CUSTOMER'S LATERJET GLENOID 2.9MM DRILL BIT BROKE INSIDE THE PATIENT BUT DID NOT COME OFF THE DEVICE. THE SALES REP CONFIRMED THE PIECE WAS STILL ATTACHED TO THE DEVICE WHEN REMOVED FROM THE PATIENT'S JOINT SPACE. THE SURGEON HAD COMPLETED THE PROCEDURE WITH THE DEVICE AT THE TIME. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256725 ↗
• MalfunctionDec 27, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ARTHROSCOPIC LATARJET SURGICAL PROCEDURE WHILE USING A DISTAL TIBIA ALLOGRAFT, THE SURGEON WAS USING THE 2.9MM GLENOID CANNULATED DRILL BIT AND THE DRILL BIT BROKE INSIDE THE GRAFT AND GLENOID OF THE PATIENT. THE SURGEON WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN PIECE OF THE DRILL BIT WITHOUT ANY HARM TO THE PATIENT. WE HAD TO OPEN UP ANOTHER LATARJET SET TO GET THE 2.9MM GLENOID CANNULATED DRILL BIT FROM THERE TO FINISH THE SURGERY. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE, INCLUDING IF THERE WAS A DELAY IN SURGERY, WHETHER FRAGMENTS WERE GENERATED, IF THERE WAS ANY OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED, AND IF THE PATIENT IS A PART OF A CLINICAL STUDY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8201088 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING A LATARJET SHOULDER PROCEDURE, THE CUSTOMER'S LATARJET GLENOID DRILL BIT BROKE IN THE PATIENT'S BONE. THE FRAGMENT WAS REMOVED. THE PATIENT HAD HARD BONE, AND THIS CAUSED A 30 MINUTE DELAY. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7805605 ↗