BRISTOW LATARJET 285270Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705018000), received between Mar 13, 2020 and May 28, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LOAN KIT PRODUCT INSPECTION IT WAS OBSERVED THAT THE LATARJET CURVED OSTEOTOME DEVICE WAS COMPOSED OF 1 PART. IT WAS OBSERVED THAT THE BOTTOM METAL PART OF THE DEVICE HAD COME OFF FROM THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322395 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED FROM AUSTRALIA THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LATARJET CURVED OSTEOTOME DEVICE WAS BROKEN INTO TWO PIECES ON THE CONSIGNED LATARJET TRAY. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970416 ↗
• MalfunctionMar 20, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HANDLE ON THE CURVED OSTEOTOME DEVICE APPEARED LOOSE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 16574456 ↗
• MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING KIT INSPECTION, IT WAS OBSERVED THAT THE IMPACTING PLATE ON THE CURVED OSTEOTOME DEVICE HAD COME OFF FROM THE HANDLE ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545392 ↗
• MalfunctionSep 20, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SILVER PIECE AT THE TOP OF THE CURVED OSTEOTOME DEVICE WAS MISSING. 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 15457564 ↗
• MalfunctionJul 26, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE CURVED OSTEOTOME DEVICE WAS MISSING THE SILVER CAP ON THE BACK. 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 15103340 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CURVED OSTEOTOME DEVICE WAS BROKEN. 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 14605161 ↗
• MalfunctionJul 29, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6). THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET CURVED OSTEOTOME DEVICE WAS BLUNT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF ONE MINUTE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247077 ↗
• MalfunctionJul 13, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6 2021, IT WAS OBSERVED THAT THE LATARJET CURVED OSTEOTOME DEVICE WAS BLUNT. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160775 ↗
• MalfunctionMay 26, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING A LATARJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE CURVED OSTEOTOME WAS BLUNT. 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 11886218 ↗
• MalfunctionSep 29, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT THE LOAN KIT TECHNICIAN REPORTED THAT DURING LOAN KIT INSPECTION, WHEN IMPACTING HEAD/AREA OF A CURVED OSTEOTOME HANDLE HAS BROKEN OFF (NOT RETURNED). IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603516 ↗
• MalfunctionMar 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT BEFORE A LATARJET PROCEDURE THE SCRUB NURSE NOTED THAT THE CUTTING TIP OF THE LATARJET CURVED OSTEOTOME WAS DAMAGED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832463 ↗