BRISTOW LATARJET 285220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705017904), received between Jan 16, 2019 and Nov 14, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HEXAGONAL END ON THE 2.5MM CANNULATED SCREWDRIVER DEVICE WAS BURRED ROUND AND SPINNING IN THE GLENOID SCREW. ACCORDING TO THE REPORT, THE DEVICE WAS INEFFECTIVE IN TURNING THE SCREW. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS DEFORMED ON THE DISTAL PART OF THE TIP. IT WAS REPORTED THAT THE GUIDE WIRE WAS REMOVED AND TIGHTENED SCREW WITH A NON-CANNULATED SCREWDRIVER TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15791025 ↗
• MalfunctionOct 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET CANN. SCREWDRIVER DEVICE WAS STRIPPED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP ON THE DEVICE WAS DEFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638982 ↗
• MalfunctionJul 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM THE AFFILIATE THAT THE LATARJET CANN. SCREWDRIVER DEVICE BOLTS THAT HOLD THE DRIVER SHAFT IN THE HANDLES CAN COME LOOSE OR HOLD DEBRIS UNDER THEM. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP OF THE SCREWDRIVER WAS DEFORMED AND BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12190014 ↗
• MalfunctionSep 16, 2019Material Deformation; Material Deformation

  DURING LATARJET PROCEDURE, WHEN SURGEON TRIED TO PLACE SCREW DRIVER OVER GUIDE WIRE THE TIP WOULD NOT FIT. THE TIP WAS BENT SO THE DRIVER WOULD NOT SLIDE OVER K WIRE. THERE IS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9069958 ↗
• MalfunctionJan 16, 2019Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER PROCEDURE IT WAS FOUND THAT TWO OF THEIR LATARJET CANNULA SCREW DRIVERS ARE STRIPPED AND BROKEN. THE SALES REP CONFIRMED THAT NOTHING BROKE IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DIFFERENT TYPE OF DRIVER WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254530 ↗
• MalfunctionJan 16, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT TWO OF THE LATARJET CANNULA SCREW DRIVERS ARE STRIPPED AND BROKEN. THE SALES REP CONFIRMED THAT NOTHING BROKE IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DIFFERENT TYPE OF DRIVER WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254338 ↗