INHANCE 6205-10-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 337 adverse event reports that list this exact device (DI 10603295539407), received between Nov 9, 2021 and Sep 30, 2026 — classified as 337 malfunctions.

The most frequently reported specific device problem is “Break” (289 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 337 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that an artificial shoulder joint surgery for CTA was performed on (b)(6) 2026. During the surgery, the IMPACTOR TIP broke while in use. The surgery was completed without issues. There was no surgical delay. There was no harm to the patient. No device remained in the patient. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947461 ↗
• MalfunctionSep 24, 2026Crack; Material Deformation

  It was reported the Concave Impactor Tip was damaged during standard impaction; it could no longer be put together with the Impactor Handle. The threads were cracked/bent. The procedure was completed with no significant delay or harm to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883741 ↗
• MalfunctionSep 21, 2026Break

  It was reported that during an unknown surgery, the connection portion of the device to the impactor handle chipped. It was unknown if fragments were generated. The event happened after completion of impaction. Therefore, the event did not impact the surgery. The surgery was completed with no issues. There was no surgical delay and there was no harm to the patient. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844331 ↗
• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50178391 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE GLENOSPHERE INSERTER TIP THREADS STRIPPED T-HANDLE MODULAR GLENOIND BASE PLATE AND GLENOSHERE INSERTER THREADS STRIPPED. ADDITIONALLY, 2X STAR 20 SCREW DRIVERS WERE STRIPPED. ALL DEVICES ARE INTACT. NO DELAYS AS THE REPORTER HAVE BACKUP. NO HARM TO PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714923 ↗
• MalfunctionMay 14, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION AND THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175260 ↗
• MalfunctionMay 14, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION AND THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175135 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT IMPACTOR BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028502 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT THE INSERTER TIP SNAPPED DURING THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931255 ↗
• MalfunctionApr 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE IMPACTOR TIP WAS DAMAGED ON THE SURFACE. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857007 ↗
• MalfunctionApr 8, 2026Break; Crack

  IT WAS REPORTED THAT THE T-HANDLE IS STRIPPED AND THE HEAD IMPACTOR CRACKED INTO 3 PIECES. THE HEAD IMPACTOR WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819454 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT THE GLENOID HEAD IMPACTOR BROKE AT THE BACK DURING IMPLANT IMPACTION. IT DID NOT DELAY THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818497 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT THE INHANCE CONCAVE IMPACTOR TIP WAS NOTICED TO HAVE A CRACK IN IT. THIS OCCURRED IN SPD. THIS IS THE ORIGINAL ALL POLY IMPACTOR TIP. A BROKEN INHANCE IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649078 ↗
• MalfunctionMar 11, 2026Crack

  IT WAS REPORTED THAT THE CONCAVE IMPACTOR TIPS ARE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574808 ↗
• MalfunctionMar 11, 2026Crack

  IT WAS REPORTED THAT THE CONCAVE IMPACTOR TIPS ARE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568486 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT IMPACTOR WAS DISCOVERED TO BE BROKEN UPON INSPECTION PRIOR TO SURGERY. IT WAS NOT USED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505281 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT THE CONCAVE IMPACTOR TIP BROKE DURING IMPACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201791 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THE CONCAVE ENHANCE IMPACTOR TIP BROKE WHILE IMPACTING GLENOSPHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888815 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN TRAY PRIOR TO GOING TO SPD FOR NEXT CASE. THE CASE DID NOT HAPPENED DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838036 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT THE CONCAVE IMPACTOR TIP WAS BROKEN BEFORE USED. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582397 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT CONCAVE IMPACTOR BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556544 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON IMPACTED GLENOSPHERE AND TIP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527003 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT THE CONCAVE IMPACTOR TIP CHIPPED AND A PIECE BROKE OFF UPON IMPACTION DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512928 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGERY, THE IMPACTOR BROKE WHEN IMPACTING THE ADAPTER TO THE HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486841 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE IMPACTOR WAS THE OLD STYLE, ALL PLASTIC. IT BROKE AT THE THREAD INTERFACE WHEN IMPACTING THE IMPLANT DURING A LEFT TOTAL SHOULDER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401732 ↗