BRISTOW LATARJET 285111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705020621), received between Jan 14, 2019 and Jan 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K110763); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN OPEN LATERJET SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BRISTOW-LATARJET 28MM SCREW,TOP-HAT(1) DID NOT "BIT" AND THE TOP HAT BACKED OUT OF THE CORACOID. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHEN THE SURGEON IMPLANTED THE TOP HAT. IT WAS FURTHER REPORTED THAT THE IMPLANTS WERE REMOVED AND DISCARDED. A SMALL SCREW AND WASHER HAD TO BE USED TO COMPLETE THE PROCEDURE WITH NO NEW HOLE. THERE WAS A MINUTE DELAY IN THE SURGICAL 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; Not Applicable

  MAUDE report 8245040 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110763. One submission often covers many models, so check the product and lot details in each record.

• Z-2619-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by suppor
• Z-2616-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting
• Z-2617-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by su
• Z-2615-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by suppo
• Z-2618-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting t