BRISTOW LATARJET 285126Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705020683), received between Jan 11, 2019 and Jan 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE TOP HAT BROKE DURING USE. ACCORDING TO THE REPORTER, THERE WERE TWO SCREWS IMPLANTED ACCORDING TO THE OPERATIVE RECORD, HOWEVER, IT WAS UNKNOWN WHICH OF THESE SCREWS EXPERIENCED THE ISSUE; THEREFORE, BOTH CODES WERE REPORTED. ACCORDING TO THE EVENT DESCRIPTION ONLY ONE TOP HAT BROKE. IT WAS FURTHER REPORTED THAT TWO SCREWS WERE IMPLANTED; HOWEVER, IT WAS UNKNOWN TO WHICH SCREW THE ISSUE WAS ATTRIBUTED TO. IT WAS REPORTED THAT THE TOP HAT BROKE WHEN IT WAS BEING INSERTED INTO THE BONE, NOT WHEN THE SCREW WAS INSERTED. THERE WAS NO SURGICAL DELAY. THE SURGEON USED ANOTHER TOP HAT TO COMPLETE 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 8254140 ↗
• MalfunctionJan 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING LATARJET SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BRISTOW-LATARJET 34MM SCREW,TOP-HAT(1) SCREW HEAD STRIPPED. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHILE THE SURGEON WAS SCREWING THE DEVICE INTO PATIENT'S GLENOID WHEN THE SCREW HEAD STRIPPED. IT WAS FURTHER REPORTED THAT THE SURGEON WAS NOT ABLE TO IMPLANT SCREW ANY FURTHER, BUT WAS ABLE TO UNSCREW IT OUT. IT WAS REPORTED THAT THE SURGEON HAD TO DRILL A NEW HOLE AND IMPLANTED A NEW SCREW. IT WAS REPORTED THAT THE LOT NUMBER COULD NOT BE DETERMINED. IT WAS REPORTED THAT A NEW HOLE WAS CREATED BECAUSE THE SURGEON WAS NOT CONFIDENT OF WHERE THE ORIGINAL HOLE WAS LOCATED. IT WAS REPORTED THAT THE HOLES WERE DRILLED WITH A 3.2 DRILL BIT. IT WAS REPORTED THAT AND THE PATIENT'S BONE QUALITY WAS VERY HARD. IT WAS REPORTED THAT THERE WAS A 15 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 8241390 ↗

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-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-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
• 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-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-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