INHANCE 6201-01-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10603295539315), received between Jun 3, 2022 and Sep 29, 2026 — classified as 98 malfunctions.

The most frequently reported specific device problem is “Break” (95 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931071 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT THE HUMERAL PIN PUNCH CAME APART WHEN IN THE PATIENT'S HUMERUS. INSTRUMENT CAME APART WHILE IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521897 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT THE PIN WELD BROKE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486821 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE HUMERAL STEM PIN PUNCH WAS BROKEN, MUST BE REPLACED AS ONE OF ITS PRONGS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109697 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THE DEVICE WAS FOUND BROKEN IN CENTRAL SUPPLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014430 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING WASHING. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860415 ↗
• MalfunctionApr 9, 2026Break

  IT WAS OBSERVED BY CENTRAL SUPPLY THAT THE HUMORAL STEM PUNCH WAS BROKEN. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828981 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT ON UPON OFFICE IN HOUSE INSPECTION, IT WAS FOUND THAT THE INSTRUMENT WAS BROKEN. NO PREVIOUS CASES WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811646 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, ONE PIN CAME OFF THE PIN PUNCH HANDLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680473 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGERY, WHILE USING THE HUMERAL STEM PIN PUNCH, PINS BROKE OFF. THEY WERE REMOVED FROM THE PATIENT WITH A PIN DRIVER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430594 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THE PIN PUNCH BROKE WHILE BEING PULLED OUT OF THE HUMERUS. THE EVENT DID NOT AFFECT THE CASE, AND THE T20 WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248118 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT DURING ROUTINE OFFICE INSTRUMENT INSPECTION IT WAS OBSERVED THAT THE HUMERAL STEM PIN PUNCH DEVICE WAS BROKEN INTO TWO PIECES, AND THE DURALOC STR CUP IMPACTOR HANDLE WAS CRACKED. NO SURGICAL INCIDENT REPORTED AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193565 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT PIN PUNCH BROKE WHEN PREPPING FOR DISTAL STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188830 ↗
• MalfunctionJan 16, 2026Break

  INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092453 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT WHEN EXTRACTING THE HUMERAL STEM PIN PUNCH, ONE OF THE PINS BROKE OFF. IT WAS RETRIEVED AND THE MEDIUM GLENOID SIZER CRACKED WHILE PUTTING IT ON THE SIZER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658877 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT THE PIN OF THE INHANCE PIN PUNCH DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544177 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT THE PIN PUNCH WAS PLACED IN HUMERUS WITH THE BLAZER. WHEN REMOVED, ONE OF THE PINS DETACHED FROM THE PUNCH. ALL PARTS WERE RETRIEVED AND THERE WERE NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23370798 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT WHEN USING THE HUMERAL STEM PIN PUNCH, ONE OF THE 2 PRONGS BROKE OFF. IT WAS RETRIEVED FROM THE PATIENT, NO HARM WAS DONE, AND THERE WERE NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337499 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT STAFF HAD (2) TWO ITEMS BREAK IN THE CASE. THE FIRST WAS THE STEM PUNCH. ONE OF THE PEGS BECAME LOOSE FROM THE PUNCH. ALL PIECES WERE RETRIEVED. THE SECOND WAS THE THREADS STRIPPING ON THE GLENO-SPHERE IMPACTOR. EVERYTHING WAS RETRIEVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065283 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED BY SPD THAT THE INSTRUMENT BROKE DURING WASHING. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992467 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT THE HUMERAL PIN PUNCH BROKE, IT PULLED OUT OF THE PUNCH WHEN REMOVING FROM THE HUMERUS. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918535 ↗
• MalfunctionMar 27, 2025Break; Break

  IT WAS REPORTED THAT THE INHANCE STEM PUNCH "CHOPSTICKS" BROKE DURING USE. ALL PIECES WERE RETRIEVED AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708091 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER CASE PERFORMED BY SURGEON, THE HUMERAL STEM PIN PUNCH WAS BROKEN DURING INSERTION. THE FRAGMENTED PIECES WERE ABLE TO BE RETRIEVED INTACT AND THE CASE WAS COMPLETED WITH NO ADVERSE PATIENT RESULTS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583367 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT BROKEN PUNCH FROM LOANER SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548528 ↗
• MalfunctionFeb 24, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECIEVED AS FOLLOWS: 1. SURGERY WAS DELAYED FOR TWO OR THREE MINUTES WHILE WE LOCATED A PAIR OF PLIERS TO REMOVE. 2. THE PATIENT WAS NOT ADVERSELY AFFECTED. 3. THE DEVICE WAS BROKEM INTO TWO PIECES. ONE OF THE PRONGS ON THE STEM PIN PUNCH DISASSOCIATED FROM THE PROXIMAL PORTION OF THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445648 ↗