NA 288241Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705027316), received between Apr 13, 2017 and May 12, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A LATARJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET, GLENOID DRILL DEVICE WAS BENT WHILE DRILLING THROUGH GLENOID. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A MINUTE OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813630 ↗
• MalfunctionMar 24, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DRILL DEVICE WAS DULL. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563522 ↗
• MalfunctionNov 27, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ARTHROSCOPIC LATARJET PROCEDURE WHILE DRILLING THE GLENOID, THE SURGEON REPORTED THAT THE LATARJET, GLENOID DRILL APPEARED BLUNT, AS IT WAS VERY DIFFICULT TO DRILL THROUGH THE BONE. ACTION TAKEN TO MANAGE THE ISSUE: OPEN UP ALTERNATE TRAY, USE DRILL BIT (IDENTICAL) OFF THAT TRAY, TO COMPLETE THE TASK. 3 MINUTE DELAY TO THE PROCEDURE. NO AE TO PATIENT.

  Patient problems: Not Applicable

  MAUDE report 9385720 ↗
• MalfunctionApr 19, 2019Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DRILL BROKE. IT WAS NOTED A DRILL FRAGMENT WAS RETAINED AND THE PATIENT REQUIRES A REVISION. THIS REPORT IS FOR A LATARJET, GLENOID DRILL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 8532162 ↗
• MalfunctionJan 3, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT AFTER DRILLING THE GLENOID DURING AN ARTHROSCOPIC LATERJET, IT WAS OBSERVED THAT UPON REMOVAL OF THE DRILL, IT LEFT BEHIND THE DISTAL TIP THAT APPEARED TO HAVE CLEANLY SNAPPED AT THE JUNCTION WHERE THE DRILL BIT THINS (APPROX 5CM) OUT. AFFILIATE STATED THAT IT WAS REMOVED WITH OTHER STANDARD ARTHROSCOPIC INSTRUMENTATION WITHOUT ANY HARM TO THE PATIENT. THE CASE WAS COMPLETED BY THE REMOVAL OF IT USING THE NEEDLE HOLDER. THERE WAS A THREE MINUTE SURGICAL DELAY REPORTED. AFFILIATE ADDED THAT THERE WERE NO FRAGMENTS GENERATED AND NO MEDICAL INTERVENTION REQUIRED. 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: Not Applicable

  MAUDE report 8212199 ↗
• MalfunctionMay 18, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE GLENOID DRILL BIT BROKE. THE DEVICE WAS IN CONTACT WITH THE PATIENT, BUT THERE WAS NO PATIENT IMPACT. THE SURGEON USED A NEW DRILL BIT FROM ANOTHER ANCILLARY. THERE WAS A 5-MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7525441 ↗
• MalfunctionApr 2, 2018Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING A SHOULDER PROCEDURE, THE CUSTOMER'S LATARJET DRILL BIT SNAPPED OFF IN THE PATIENT. THE DOCTOR REMOVED THE FRAGMENT WITH A GRASPER AND USED ANOTHER DRILL BIT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES, AND THE DELAY WAS LESS THAN 5 MINUTES. THE DEVICE IS BEING RETURNED. THE SALES REP REQUESTED THE OLDER LATARJET DRILL BIT BE SENT TO THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7390197 ↗
• MalfunctionMar 27, 2018Break; Break

  SALES REP REPORTS A BROKEN DRILL DURING A SURGERY. THE BREAK HAPPENED AT THE JUNCTION BETWEEN THE HANDLE AND THE THREAD. USE OF ANOTHER INSTRUMENT TO FINISH THE SURGERY WITH SUCCESS. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7374874 ↗
• InjuryDec 21, 2017Break; Break

  THE WICK BROKE DURIN PROCEDURE. (ANCILLARY N°12). PROCEDURE HAS BEEN EXTENDED FOR AN HOUR . NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7139339 ↗
• MalfunctionApr 13, 2017Break; Break

  THE AFFILIATE REPORTED VIA EMAIL DURING A SHOULDER PROCEDURE, WHILE DRILLING INTO THE (GLENOID) BONE ,THE PEAK OF DRILL BROKE AND WAS STOCK IN THE BONE (GLENOID). WITH QUITE SOME (TIRING) TRYING, THE SURGEON WAS ABLE TO GET THE DRILL OUT AGAIN. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 4-13-17: THE BROKEN PIECE WAS ABOUT 10CM. THE SURGEON MANAGED TO PULL THE BROKEN PIECE OUT OF THE BONE AND FINISHED THE SURGERY NORMALLY ¿ EVERYTHING WENT WELL AFTER THAT INCIDENT ¿ NO HARM ON PATIENT OR OTHER FAILURE. THE ORIGINAL BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. NO, THEY WERE NO NEED TO DRILL ANOTHER WHOLE. THE COMPLAINT DEVICE IS COMING BACK FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6491898 ↗