INHANCE 6505-10-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 10603295547631), received between Aug 31, 2022 and Sep 28, 2026 — classified as 2 injuries, 207 malfunctions.

The most frequently reported specific device problem is “Break” (165 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 209 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919692 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829720 ↗
• MalfunctionSep 14, 2026Break; Device-Device Incompatibility

  It was reported that the small screwdriver tip broke off in the glenosphere implant and could not be retrieved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759329 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676128 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045979 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045977 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045968 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER REPAIR. THE SCREW DRIVER TIP BROKE OFF IN THE GLENOSPHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510516 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT SCREWDRIVER BIT WAS SHEARED AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25509488 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT THE SCREWDRIVER BLADE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411177 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT SCREWDRIVER TIP SHEERED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353737 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGERY, AS THE LOCKING SCREWS WERE BEING INSERTED THE TIP OF THE STAR 20 BROKE OFF INTO THE HEAD OF THE SCREW. THE TIP WAS RETRIEVED, THERE WAS NO HARM TO THE PATIENT. THERE WAS NO DELAY IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334982 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT THE DURING A RIGHT SHOULDER REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT TIP OF THE STAR 20 DRIVER WAS BROKE OFF FLUSH AT DISTAL TIP WHEN TIGHTENING SCREWS. IT WAS REPORTED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300971 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY THE SURGEON WAS TIGHTENING THE SCREW IN THE GLENOSPHERE WHEN THE SURGEON FELT THE SCREWDRIVER BEGIN TO SLIP, AND UPON INSPECTING THE SCREWDRIVER THEY NOTED THE TIP WAS FRACTURED OFF. THE SURGEON SEARCHED FOR THE TIP, COULD NOT FIND IT, AND CONCLUDED IT WAS EITHER INSIDE THE GLENOSPHERE OR HAD FRACTURED BEFORE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219155 ↗
• MalfunctionMay 19, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT SCREWDRIVER TIP BROKE WHILE INSERTING PERIPHERAL SCREW. BROKEN TIP WAS STUCK IN SCREW HEAD AND WAS RETAINED IN THE PATIENT WAS ABLE TO FINISH CASE WITH BACK UP SCREWDRIVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 25216395 ↗
• 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 25210735 ↗
• MalfunctionMay 14, 2026Material Deformation

  IT WAS REPORTED THAT AFTER THE CASE AND DECONTAMINATION, THE SETS WERE PUT BACK TOGETHER AND INSPECTED. IT WAS NOTICED THAT THE T20 WAS STRIPPED. THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175602 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT SCREWDRIVER TIP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163198 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT THE SCREWDRIVERS BLADE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125483 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT SCREWDRIVER TIP BROKE WHILE INSERTING PERIPHERAL SCREW. BROKEN PIECE WAS RETRIEVED. CASE WAS FINISHED WITH ANOTHER SCREWDRIVER. NO DELAY OR EXTENDED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122982 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT THE 20 STAR DRIVER TIP BROKE WHEN INSERTING THE GLENOSPHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25106852 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER REPAIR SURGERY THE STAR DRIVER 20 TIP BROKE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094562 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN ATTEMPTING TO PLACE SOME PERIPHERAL BASEPLATE SCREWS, THE SURGEON COMPLAINED THAT SCREWDRIVER WAS NOT WORKING. IT WAS REPORTED THAT THE SURGEON OPENED ANOTHER SET AND GRABBED A DIFFERENT SCREWDRIVER WHICH WORKED BETTER. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED A COUPLE OF MINUTES. WHEN EXAMINING THE INSTRUMENT AFTER IT WAS CLEANED IT APPEARED THE END OF THE DRIVER SHEARED OFF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966783 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966597 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT THE SCREWDRIVER BROKE WHILE INSERTING A SCREW. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911874 ↗