INHANCE 6205-10-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295539391), received between Nov 29, 2022 and Apr 13, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE SCREWDRIVER WAS TWISTED AND BROKEN AT THE WELD TO THE BOLT. THE PROCEDURE WAS DELAYED FOR THIRTY (30) MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860139 ↗
• MalfunctionApr 13, 2026Break; Device-Device Incompatibility; Material Deformation; Mechanical Jam

  IT WAS REPORTED THE SCREWDRIVER WAS TWISTED AND BROKEN AT THE WELD TO THE BOLT. THE PROCEDURE WAS DELAYED FOR THIRTY (30) MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 24860043 ↗
• MalfunctionMar 12, 2026Break; Device-Device Incompatibility; Material Deformation; Mechanical Jam

  DURING AN INHANCE SHOULDER PROCEDURE: MULTIPLE INSERTER RODS, STRIPPED, BROKEN. ORIGINALLY REPLACED BY CUSTOMER. REPEATED ISSUE WITH SAME INSTRUMENTS. THERE WAS A SURGICAL DELAY OF THIRTY MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579443 ↗
• MalfunctionMar 9, 2026Break; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THE INSTRUMENTS WERE STRIPPED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544690 ↗
• MalfunctionMar 9, 2026Break; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THE INSTRUMENTS WERE STRIPPED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544597 ↗
• MalfunctionMar 9, 2026Break; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THE INSTRUMENTS WERE STRIPPED AND BROKEN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544087 ↗
• MalfunctionJan 16, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT PT HAD LEFT REVERSE TSA. DURING GLENOSPHERE INSERTION, THE THREADS ON INSERTER BROKE IN SPHERE, LIMITING THE ABILITY TO ADVANCE THE LOCKING SCREW. THIS ADDED 20 MINUTES TO THE CASE. WE HAD TO DRILL AND BURR OUT THE BROKEN PIECE TO ADVANCE LOCKING SCREW IN A DEFINITIVE POSITION. A SMALL AND LARE SCREWDRIVER WERE ALSO DAMAGED DURING THE REMOVAL OF BROKEN PIECES. THE BROKEN PIECE WAS REMOVED IN ITS ENTIRETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092356 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT INSTRUMENTS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435231 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT INSTRUMENTS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435218 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT INSTRUMENTS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435204 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTATION BROKE FROM THE SET. IT WAS NOTICED BEFORE THE CASE. A NEW SET WAS BROUGHT TO NOT DELAY THE CASE. THERE WAS NO DELAY. NO BROKEN PIECES LEFT ON FIELD OR PATIENT. NO SURGEON COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088721 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THE PRODUCTS BROKE OFF IN ONE ANOTHER. THERE WAS A FEW MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946330 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184028 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SHOULDER REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 18595325 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SHOULDER REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 18595323 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SHOULDER REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 18595231 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW DRIVER GOT STUCK IN INSERTED TIP. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580883 ↗
• MalfunctionJan 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DRIVER WILL NOT DISASSEMBLE FROM INSERTER. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572090 ↗
• MalfunctionJan 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSERTER COLD WELDED TO THE LONG SCREWDRIVER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551854 ↗
• MalfunctionDec 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW DRIVER WAS STUCK IN THE INSERTED TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400902 ↗
• MalfunctionNov 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE ATTEMPTING TO ASSEMBLE THE GLENOSPHERE INSERTER TIP AND BASEPLATE T-HANDLE, THE THREADS WERE STRIPPED ON BOTH PIECES. AS A RESULT OF THIS THE STAR DRIVE 30 WAS USED AS A HANDLE TO INTRODUCE THE GLENOSPHERE. THE STAR DRIVE 30 SEEMS TO BE COLD WELDED INTO THE GLENOSPHERE INSERTER TIP. NO PIECES WERE BROKEN OFF AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136957 ↗
• MalfunctionOct 11, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE WHEN THE SALES CONSULTANT WAS PUTTING TOGETHER THE TRAYS IT WAS NOTICED THAT THE T30 SCREW DRIVER SHAFT SEEMED TO BE STRIPPED. SALES CONSULTANT REMOVED THAT FROM THE SET AND FILLED OUT THIS DER. THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912154 ↗
• MalfunctionAug 31, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TIP OF THE SCREWDRIVER WAS DAMAGED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666120 ↗
• MalfunctionAug 24, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON BROKE THE IMPACTOR HEAD WHILE IMPACTING THE GLENOSPHERE. ALSO, THE SMALL SCREWDRIVER SHAFT HAD BEEN TWISTED AND THE LARGE SCREWDRIVER HAD BEEN OVER TORQUED AND WOULD NOT COME OUT OF THE SCREWDRIVER HANDLE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17614496 ↗
• MalfunctionAug 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW DRIVER WAS STUCK ON GLENOSPHERE INSERTER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550483 ↗