INHANCE 6201-20-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 10603295539360), received between Nov 17, 2021 and Sep 22, 2026 — classified as 1 injury, 181 malfunctions.

The most frequently reported specific device problem is “Break” (159 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 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that it did not happen in surgery. The impacted product had an unknown allegation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854177 ↗
• MalfunctionSep 14, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764672 ↗
• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50760559 ↗
• MalfunctionAug 5, 2026Break

  It was reported that the adaptor trial broke while screwing it on. It was reported that there was no harm to the patient and no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146277 ↗
• MalfunctionJul 6, 2026Crack

  IT WAS REPORTED THE INSTRUMENTS WERE CRACKED AND WORN. EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25715011 ↗
• MalfunctionJun 12, 2026Crack

  IT WAS REPORTED THAT OFFSET TRIAL IS CRACKED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486101 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGERY, THE STAR DRIVER 20 HEX TIP AND THE HUMERAL HEAD TAPER ADAPTER TRIAL WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210738 ↗
• MalfunctionMay 18, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201760 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE ANATOMIC TRIAL ADAPTER SHATTERED DURING ADJUSTMENT. THIS OCCURRED AWAY FROM THE PATIENT, AND NO PIECES WERE FOUND IN THE PATIENT. THE SURGEON WAS ABLE TO FINISH THE SURGERY WITH A SECOND ADAPTER FROM THE TRAY. THERE WAS NO DELAY OR EXTENDED SURGICAL TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164230 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE TRIAL TAPER ADAPTER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115966 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT TRIAL TAPER ADAPTER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108727 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT TRIAL TAPER ADAPTER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108723 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PIECE BROKE WHEN REMOVING IT FROM THE TRIAL HUMERAL HEAD. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031956 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PIECE BROKE WHEN REMOVING IT FROM THE TRIAL HUMERAL HEAD. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027796 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE CHIPPED UPON INSPECTION IN WAREHOUSE. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793120 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE ADAPTER BROKE WHILE TRIALING AND DID NOT CAUSE A DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714347 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT WHEN OPENING THE SET, IT WAS DISCOVERED THAT A PIECE OF THE OFFSET TRIAL ADAPTER WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557522 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT AN INHANCE OFFSET TAPER ADAPTER TRIAL HAS BROKEN WITH PROPER USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH OTHER TAPER ADAPTER TRIAL USED. THE SURGERY WAS DELAYED FOR A MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512161 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED DURING STERILE PROCESSING IT WAS NOTICED THE LOCKING RING ON THE BACK OF THE OFFSET TAPER ADAPTER TRIAL WAS BROKEN. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505698 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED DURING STERILE PROCESSING IT WAS NOTICED THE LOCKING RING ON THE BACK OF THE OFFSET TAPER ADAPTER TRIAL WAS BROKEN. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505696 ↗
• MalfunctionMar 2, 2026Break

  PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2026. THE INHANCE OFFSET TAPER ADAPTER TRIAL BROKE WITH PROPER USE. ANOTHER TAPER ADAPTOR WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A ONE MINUTE DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489591 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THE OFFSET TAPER ADAPTER TRIAL BROKE DURING A PROCEDURE. ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A MINUTE DELAY AND NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485905 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE TRIAL DEVICE BROKE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, THE DATE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455886 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE TRIAL DEVICE BROKE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO PATIENT INVOLVEMENT. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. THE DATE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455784 ↗
• MalfunctionFeb 5, 2026No Apparent Adverse Event

  IT WAS REPORTED DEVICES WERE RECEIVED AS A BLIND UNIT. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266886 ↗