BRISTOW LATARJET 285121Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705020669), received between May 8, 2019 and May 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) VIA EMAIL THAT THE BRISTOW LATARJET 32MM SCREW HAD A FAILURE DURING THE LATARJET SURGICAL PROCEDURE. THE AFFILIATE STATED THAT THE DOCTOR FOLLOWED THE SURGICAL TECHNIQUE INDICATED FOR THE PRODUCT. IT WAS REPORTED THAT AT THE TIME OF SCREWING CORRECTLY IN POSITIONING THE CORACOID, THE SCREW DIDN'T COMPRESS BUT WAS ROLLED. IT WAS MENTIONED THAT THE SCREW MUST BE REPLACED BY ANOTHER ONE. THERE WAS AN HOUR DELAY IN THE SURGERY. THERE WAS PATIENT CONSEQUENCE OF PUTTING A NEW SCREW (THAT WAS SAME DIAMETER MEASURE AS THE ONE THAT FAILED) THE CORACOID GRAFT DETACHED, AS IT COULD BE SEEN NEXT DAY ON X-RAYS. IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TWO DAYS AFTER THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 8592268 ↗

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-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-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-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-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