NA 288211Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705026890), received between Mar 4, 2017 and Apr 28, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 12, 2017Terminated

   Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

   Z-2615-2017 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Degraded; Device 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 2 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 25015917 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE COMBO SCREWDRIVER DEVICE BROKE/ SNAPPED DURING A REMOVAL. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 24388289 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A LATARJET PROCEDURE, THE COMBO SCREWDRIVER DEVICE WHILE SCREWING THE TIP OF THE SCREWDRIVER, BROKE INSIDE THE SCREW. A REPLACEMENT SCREWDRIVER FROM THE HOSPITAL WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810214 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT DURING PRE-SURGERY FOR AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE COMBO SCREWDRIVER DEVICE TIP WAS BROKEN. IT WAS REPORTED THAT THE SURGEON MANAGED TO FIX THE BROKEN TIP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO 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 23567734 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE COMBO SCREWDRIVER DEVICE TIP WAS BROKEN AND THE DEVICE WAS UNUSABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 22335176 ↗
• MalfunctionJan 23, 2025Degraded; Degraded

  IT WAS REPORTED FROM AUSTRALIA THAT TWO SETS OF DEVICES HAD BLUNT INSTRUMENTS. IT WAS REPORTED THAT THE TWO CORACOID TOP HAT DRILL DEVICES, TWO SHARP CURVED OSTEOTOME DEVICES, A COMBO SCREWDRIVER, AND A CORACOID OFFSET PIN WERE BLUNT. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 5 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217230 ↗
• MalfunctionJul 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT DURING AN UNSPECIFIED SHOULDER SURGICAL PROCEDURE ON (B)(6) 2024 THE COMBO SCREWDRIVER DEVICE WAS DEFECTIVE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692970 ↗
• MalfunctionApr 2, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC ANATOMIC GLENOID REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE COMBO SCREWDRIVER DEVICE STRIPPED THE SCREWS AND DID NOT GRAB. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 19021580 ↗
• MalfunctionNov 7, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY WITH GLENOID RECONSTRUCTION SURGICAL PROCEDURE THE TIP OF THE COMBO SCREWDRIVER BROKE WHILE ATTEMPTING TO INSERT THE LATER JET EXPERIENCE SCREWS. THERE WAS A 60 MINUTE SURGICAL DELAY WITH NO PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 18085707 ↗
• MalfunctionAug 16, 2022Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED BY SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE LATARJET EXPERIENCE COMBO SCREWDRIVER DEVICE HAD ISSUES ENGAGING WITH THE HEAD OF THE SCREW. THEREFORE, IT WAS MALLETED IN TO PREVENT THE SCREW FROM STRIPPING. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SCREWDRIVER NOW APPEARS TO BE BENT SLIGHTLY AT THE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233855 ↗
• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LATARJET SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SHAFT ON THE COMBO SCREWDRIVER DEVICE WAS BENT THAT IT WOULD CATCH THE WIRE WHILE ADVANCING THE SCREW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268514 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PRE-OPERATIVELY TO A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HANDLE ON THE COMBO SCREWDRIVER DEVICE WAS CRACKED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202695 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN SWITZERLAND THAT DURING AN ARTHROSCOPIC SHOULDER INSTABILITY LATARJET SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE COMBO SCREWDRIVER DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122966 ↗
• MalfunctionAug 17, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LATARJET PROCEDURE THE TIP OF THE COMBO SCREWDRIVER SPLITTED IN HALF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES. 45 MINUTES DELAY REPORTED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10414464 ↗
• MalfunctionNov 12, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE COMBO SCREWDRIVER HAD A SPLIT ON THE DISTAL TIP, AND IT APPEARED TO HAVE A CRACKED ON THE CORNER OF THE HEX. APPARENTLY THIS IS BECAUSE THIS WAS A NEWER VERSION. THE SURGEON HAD TO USED THE OLD VERSION TO BE ABLE TO PERFORMED THE PROCEDURE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE SCREW WAS REMOVED AT THE PATIENT'S REQUEST. THE AFFILIATE ALSO REPORTED THAT THE SCREW DID NOT CRACK BUT THE SCREWDRIVER CRACKED AND NO PATIENT CONSEQUENCES OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311084 ↗
• MalfunctionApr 13, 2017Break; Break

  THE AFFILIATE REPORTED VIA EMAIL THE SCREWDRIVER IS BROKEN OFF AT THE TIP. HOWEVER, THE TIP COULD BE REMOVED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH A FIVE MINUTE DELAY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 3-17-2017. THE TIP OF THE SCREWDRIVER DID FALL INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6491698 ↗
• MalfunctionMar 4, 2017Break; Break

  THE SALES REP REPORTED VIA PHONE THAT THE TIP OF THE DRIVER BROKE OFF WHILE TIGHTENING A SCREW ON THE CUSTOMER'S LATARJET COMBO SCREWDRIVER DURING A LATERJET PROCEDURE. THE PIECE WAS FOUND IN THE PATIENT AND ALL DEBRIS REMOVED. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THE SALES REP WAS NOT PRESENT BUT REPORTED NO ADVERSE PATIENT CONSEQUENCE AND A 5 MINUTE DELAY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6379189 ↗