BRISTOW LATARJET 285240Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705017942), received between Feb 15, 2018 and Nov 7, 2021 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE LATARJET CC STEP DRILL 3.2MM DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE EDGES ON THE DEVICE WERE DULL UNDER MAGNIFICATION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758970 ↗
• MalfunctionJun 10, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN AUSTRALIA THAT DURING A LATERJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 WAS BLUNT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE DESPITE THE ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975606 ↗
• InjuryMay 13, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6). THAT DURING A LATARJET PROCEDURE ON (B)(6) 2021 IT WAS OBSERVED THAT THE LATARJET CORACOID STEP DRILL 3.2MM DEVICE WAS DIFFICULT TO PASS THROUGH THE BONE. THE SURGEON PROCEEDED TO FINISH WITH AN OPEN SURGERY WITH A DELAY OF 1 HOUR AND 30 MINUTES; AND WITH PART OF THE REST OF ONE OF THE BONE PLUGS THAT REMAINED AND FIXING WITH A SINGLE LATARJET SCREW. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11820129 ↗
• MalfunctionMay 15, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LATARJET PROCEDURE TWO OF THE CORACOID STEP DRILLS WERE DULL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICES. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. ALL DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063317 ↗
• MalfunctionMay 15, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LATARJET PROCEDURE TWO OF THE CORACOID STEP DRILLS WERE DULL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICES. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. ALL DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063284 ↗
• MalfunctionMar 9, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE LATARJET GLENOID LONG DRILL BIT 3.2 AND THE LATARJET CC STEP DRILL 3.2MM WERE A BIT BLUNT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808742 ↗
• MalfunctionJul 30, 2018Dull, Blunt; Dull, Blunt

  LATARJET; XXXX XXX, (B)(6) HOSPITAL (B)(6) 2018. DURING USE IT WAS NOTED THAT THE CORACOID DRILL WAS BLUNT AND THE SOLID SCREWDRIVER WAS ROUNDED. SURGEON USED THE BLUNT & ROUNDED INSTRUMENTS, 2-3 MINUTE DELAY TO PROCEDURE.

  Patient problems: Not Applicable

  MAUDE report 7731177 ↗
• MalfunctionMay 14, 2018Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  SURGEON MENTIONED WHEN HE WAS USING THE CORACOID STEP DRILL AND THAT IT WAS DIFFICULT TO GET THROUGH THE BONE - DRILL WAS VERY BLUNT AND NEEDS REPLACING. ALSO WHEN USING THE CANNULATED SCREWDRIVER HE MENTIONED IT WAS ROUNDED - APPEARED STRIPPED AND ALSO NEEDED REPLACING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7512498 ↗
• MalfunctionApr 16, 2018Break; Break

  IT WAS REPORTED DURING A LATARJET EXPERIENCE SURGERY A CORACOID DRILL BIT BROKE. THE MEDICAL DEVICE WAS IN CONTACT WITH THE PATIENT. THE SURGERY DIDN'T STOP AND THERE WASN'T A CHANGE OF THE TECHNICAL SURGERY. A NEW DRILL BIT WAS USED IN ANOTHER ANCILLARY. THERE WAS NO CONSEQUENCE FOR THE PATIENT. A TWO (2) MINUTE SURGICAL DELAY WAS REPORTED. ADDITIONAL INFORMATION FROM AFFILIATE RECEIVED ON 09APRIL2018: THE FRAGMENT OF THE BROKEN DEVICE WAS REMOVED FROM THE PATIENT; THERE WAS NO CONSEQUENCE FOR THE PATIENT. ADDITIONAL INFORMATION FROM THE AFFILIATE RECEIVED ON 16APRIL2018: IT IS UNKNOWN HOW THE FRAGMENTS OF THE DEVICE WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A SIMILAR/LIKE DEVICE; THE ALTERNATIVES WERE READILY AVAILABLE. IT IS UNKNOWN IF THERE WERE ANY PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. IT IS UNKNOWN IF THERE IS ANY ADDITION SURGICAL INTERVENTION PLANNED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7434016 ↗
• MalfunctionFeb 15, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT TWO OF THE CUSTOMER'S LATARJET STEP DRILL 3.2MM, ONE GLENOID LONG DRILL BIT AND BRISTOW LATARJET 48MM SCREW TOP HAT WERE DULL AND THEIR LATARJET BONE SCREW RETRIEVER WAS BENT IN BETWEEN CASES. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THE DEVICES ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275061 ↗
• MalfunctionFeb 15, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT TWO OF THE CUSTOMER'S LATARJET STEP DRILL 3.2MM, ONE GLENOID LONG DRILL BIT AND BRISTOW LATARJET 48MM SCREW TOP HAT WERE DULL AND THEIR LATARJET BONE SCREW RETRIEVER WAS BENT IN BETWEEN CASES. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THE DEVICES ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275056 ↗