BRISTOW LATARJET 285300Recalls & reported problems
Medos International Sàrl · Bristow - Latarjet Instability Shoulder System Glenoid 3.2mm Drill · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bristow-Latarjet glenoid drill bit is used when repairing an unstable shoulder. Most of the 29 reports describe the bit breaking, bending, going dull, or getting clogged with bone and rust, sometimes leaving debris inside a drilled hole or delaying surgery; one report describes it breaking inside the patient. There were 2 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886705018093), received between Feb 15, 2018 and Apr 28, 2026 — classified as 2 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Break” (8 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.
Reports received per month
Most reported problems
Device problems
- Break8
- Degraded6
- Mechanical Jam4
- Dull, Blunt3
- Material Deformation3
- Delivered as Unsterile Product2
- Device Contaminated During Manufacture or Shipping2
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient9
- Unspecified Tissue Injury2
- No Patient Involvement1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT POST SURGERY, THE BRISTOW LATARJET DRILL BIT STILL HAD BONE FRAGMENTS IN THE THREADS, WHICH SUGGESTS IT WAS SIMPLY NOT PROPERLY CLEANED AFTER THE PREVIOUS CASE. IT WAS ALSO REPORTED THAT THE CANNULATED PORTION OF THE COMBO SCREWDRIVER WAS ALSO FILLED WITH BONE DEBRIS, AND WHEN IT WAS CLEANED, SMALL PARTICLES OF RUST CAME OUT. THE TRAY WAS NOT USED IN THE OR. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4). THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016053 ↗MalfunctionNov 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN DRILLING THE FINAL SCREWS, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT DEVICE HAD BONE IN THE DRILL END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23548078 ↗MalfunctionAug 25, 2025Degraded; Degraded
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE CORACOID TOP HAT DRILL DEVICE, SHARP CURVED OSTEOTOME DEVICE, LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE AND THE COMBO SCREWDRIVER DEVICE IT WAS OBSERVED THAT THE DEVICES WERE BLUNT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 OF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891174 ↗MalfunctionDec 20, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT AFTER COMPLETING A RIGHT LATARJET SHOULDER SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE THE STAFF WERE CLEANING THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE AND WERE USING A WIRE TO REMOVE BONE FROM THE CANNULATED DRILL, THE WIRE BECAME STUCK AND UNABLE TO REMOVE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20992885 ↗MalfunctionOct 18, 2024Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE BROKE INSIDE THE PATIENT. THE DRILL BIT WAS REMOVED FROM THE PATIENT. THERE WAS A TEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions
MAUDE report 20481885 ↗MalfunctionOct 1, 2024Material Deformation; Material Deformation
IT WAS REPORTED FROM AUSTRALIA THAT DURING A POSTERIOR STABILIZATION PROCEDURE, IT WAS DISCOVERED THAT THE TIP OF THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE WAS BENT, AND THE COMBO SCREWDRIVER WAS DAMAGED AND COULD NO LONGER ENGAGE THE SCREW. IT WAS NOTED THAT THE PATIENT HAD PARTICULARLY HARD BONE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions
MAUDE report 20348247 ↗MalfunctionJun 6, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING AN UNSPECIFIED SHOULDER REPAIR SURGICAL PROCEDURE THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE, WHEN USING THE GLENOID DRILL FROM AN ORTHOKIT, THE DRILL DID NOT GO OVER THE K-WIRE AS THERE WAS SOMETHING IN THE DRILL THAT PREVENTED IT FROM GOING OVER THE K-WIRE. THE OBSTRUCTION INSIDE THE DRILL COULD FINALLY BE PUSHED TO ONE SIDE WITH THE HELP OF A K-WIRE SO THAT THE DRILL COULD BE GUIDED OVER THE WIRE AND THE SURGERY COULD BE SUCCESSFULLY COMPLETED. IT WAS NOT REPORTED WHETHER THERE WAS ANOTHER DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19477214 ↗MalfunctionJan 31, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE HAD BONE STUCK INSIDE WITH SOME DEBRIS. 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 18617992 ↗MalfunctionOct 2, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GLENOID 3.2MM DRILL DEVICE WAS DAMAGED; AND THAT IT SEEMED TO HAVE A SPLIT ON THE TOP. 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 17855876 ↗MalfunctionAug 14, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GLENOID 3.2MM DRILL DEVICE DID NOT FEEL RIGHT. ACCORDING TO THE REPORT, THE SURGEON PULLED THE DRILL OUT AND NOTICED THAT HALF THE TIP OF THE CANNULATED DRILL WAS MISSING. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS AND NO ADVERSE EFFECTS. 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 17545831 ↗MalfunctionMay 9, 2023Degraded; Degraded
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GLENOID 3.2MM DRILL DEVICE WAS BLUNT. 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 16896803 ↗MalfunctionOct 19, 2022Mechanical Jam; Difficult or Delayed Separation; Mechanical Jam; Difficult or Delayed Separation
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CANNULATED BIT ON THE GLENOID 3.2MM DRILL DEVICE SEEMED A BIT TOO NARROW THAT CAUSED THE K-WIRE TO GET STUCK AND SLIDE THROUGH WITH DIFFICULTY EVEN AFTER FEEDING THE K-WIRES THROUGH TO REMOVE THE BLOCKAGE AND THE NARROWING REMAINED. 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 15634148 ↗MalfunctionJul 22, 2022Degraded; Degraded
IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GLENOID 3.2MM DRILL DEVICE WAS BLUNT. THE SAME 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 15087030 ↗MalfunctionSep 20, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A LATERJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE HAD A WIRE STUCK IN THE DRILL AFTER DRILLING THAT IT COULD NOT BE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. 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 12498094 ↗InjuryJul 23, 2021Degraded; Degraded
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LATARJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE WAS DIFFICULT TO PASS THROUGH THE BONE. THE SURGEON PROCEEDED TO FINISH WITH AN OPEN SURGERY WITH A DELAY OF 1 HOUR AND 30 MINUTES; AND WITH PART OF THE REST OF ONE OF THE BONE PLUGS THAT REMAINED AND FIXING WITH A SINGLE LATARJET SCREW. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 12217048 ↗MalfunctionJun 10, 2021Degraded; Degraded
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LATERJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 WAS BLUNT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE DESPITE THE ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11975595 ↗InjuryMay 13, 2021Degraded; Degraded
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LATARJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 DEVICE WAS DIFFICULT TO PASS THROUGH THE BONE. THE SURGEON PROCEEDED TO FINISH WITH AN OPEN SURGERY WITH A DELAY OF 1 HOUR AND 30 MINUTES; AND WITH PART OF THE REST OF ONE OF THE BONE PLUGS THAT REMAINED AND FIXING WITH A SINGLE LATARJET SCREW. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 11820096 ↗MalfunctionApr 28, 2021Break; Break
IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE LATARJET GLENOID LONG DRILL BIT 3.2 DRILL BIT BROKE OFF IN PATIENT¿S GLENOID. THE REMAINDER OF BIT WAS TAPPED THROUGH WITH REFERENCE TUBE IN LATERJET SET AND A MALLET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11739812 ↗MalfunctionOct 21, 2020Dull, Blunt; Dull, Blunt
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LATARJET PROCEDURE THE GLENOID 3.2MM DRILL WAS DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES, OR SURGICAL DELAY REPORTED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE REPORTED THE DEVICE WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED BY HOSPITAL STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10710564 ↗MalfunctionMar 9, 2020Dull, Blunt; Dull, Blunt
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE LATARJET GLENOID LONG DRILL BIT 3.2 AND THE LATARJET CC STEP DRILL 3.2 MM WERE A BIT BLUNT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9808696 ↗MalfunctionNov 5, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2029, THE DRILL BIT BROKE INTO TWO PARTS. IT WAS A CLEAN BREAK. ANOTHER DRILL BIT WAS AVAILABLE FOR USE. THERE WAS A ONE (1) MINUTE DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT EFFECTS. THIS REPORT IS FOR A LATARJET GLENOID LONG DRILL BIT 3.2. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9278580 ↗MalfunctionAug 8, 2019Break; Break
IT WAS REPORTED BY THE AFFILIATE VIA CST THAT THE CUTTING END OF THE LATARJET GLENOID LONG DRILL BIT HAS SNAPPED OFF. BROKEN PIECE NOT RETURNED. PLEASE SEE ATTACHED. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. 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 8875984 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED BY THE AFFILIATE THAT AT THE END OF A RIGHT SHOULDER ARTHROSCOPY, THE BROACH BROKE ON A LATARJET GLENOID LONG DRILL BIT. THE LAST DRILLING WAS DONE WITHOUT A PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8578381 ↗MalfunctionMar 25, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE CUSTOMER RECEIVED DIRTY INSTRUMENTS. THE AFFILIATE DID NOT PROVIDE ANY FURTHER INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8448464 ↗MalfunctionMar 25, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE CUSTOMER RECEIVED DIRTY INSTRUMENTS. THE AFFILIATE DID NOT PROVIDE ANY FURTHER INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8448194 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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