NA 288203Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705026814), received between Jun 21, 2019 and Mar 17, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2618-2017 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRE-OPERATIVE TO A LATARJET SHOULDER REPAIR PROCEDURE, IN THE DECONTAMINATION DEPARTMENT, THAT THE TOP HAT TAP INSTRUMENT (LOANER TRAY) DEVICE HAD NOTICEABLE BIOLOGICAL DEBRIS ON THE SURFACE AND WITHIN THE CANNULA. THIS WAS A PRE-OP EVENT AND WAS A NO-HARM INCIDENT, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622421 ↗
• MalfunctionJun 1, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN (B)(4) THAT DURING AN IN-HOUSE KIT INSPECTION, IT WAS DETERMINED THAT THE HANDLE ON THE TOP HAT TAP DEVICE WAS FRACTURED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14567270 ↗
• 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 TOP HAT TAP 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 12202694 ↗
• MalfunctionMay 21, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A LATARJET PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE K-WIRE WOULD NOT PASS THROUGH THE TOP HAT TAP DEVICE FROM ONE DIRECTION BUT WOULD PASS FROM THE OTHER DIRECTION. EVENTUALLY, THE PROCEDURE WAS COMPLETED WITH A DELAY OF FIVE MINUTES AS THE WIRE WAS ABLE TO GET THROUGH THE CANNULATED TAP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863006 ↗
• InjuryJun 21, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE SURGEON REPORTED THAT THE CORACOID STEP TAP WASN'T SHARP ENOUGH. THE PROCEDURE WAS ARTHROSCOPIC LATARJET. IT WAS MENTIONED THAT DURING THE PROCEDURE, STEP TAP WAS USED TO TAP DRILLED HOLE IN PREPARATION FOR TOP HAT INSERTION. THE SURGEON NOTED AT THE TIME THAT THE NEW DESIGN OF THE STEP TAP WAS DIFFICULT TO GET INTO THE BONE. WHEN THE TOP HAT WAS BEING INSERTED IN THE ALPHA-HOLE, THE LATERAL SECTION OF THE CORACOID FRACTURED. IT WAS STATED THAT THE PROCEDURE WAS CHANGED TO AN OPEN LATARJET AND ONLY ONE SCREW COULD BE INSERTED. THE SURGEON DID NOTE THAT THE BONE QUALITY WASN'T GOOD, BUT THAT THEY BELIEVED THE ISSUE WASN'T HELPED BY THE FACT THAT THE STEP TAP THREADS WOULDN'T ENGAGE AS THEY DID WITH THE PREVIOUS VERSION OF THE INSTRUMENT. THERE WAS 20 MINUTES OF SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THAT THE LOT NUMBER IS UNKNOWN AND THE PROCEDURE WAS COMPLETED. THE AFFILIATE ALSO REPORTED IT WAS UNKNOWN IF ADDITIONAL SURGICAL INTERVENTION IS REQUIRED.

  Patient problems: No Code Available; Not Applicable; Tissue Damage

  MAUDE report 8722107 ↗