Scapular Clamp 190661Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327595482), received between Apr 16, 2026 and May 5, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: CORACOID TIP WAS FRACTURED WHEN SCAPULAR CLAMP WAS PLACED. CASE COMPLETED MANUALLY. CASE TYPE / APPLICATION: RSA. UPDATE 04/10/2026: HOW WAS THE CLAMP APPLIED?: ON THE LATERAL SEGMENT ON THE CORACOID. ASIDE FROM THE CORACOID FRACTURE, WAS THERE ANYTHING UNUSUAL ABOUT THE APPLICATION/ USE OF THE CLAMP?: -NOTHING OF NOTE LEFT OR RIGHT SIDE: RIGHT HOW SEVERE/ LARGE/ SERIOUS WAS THE FRACTURE?: MINOR. THE MAIN ISSUE WAS THE INSTABILITY OF THE CLAMP. CLAMP WASN'T STABLE ON LATERAL ASPECT OF CORACOID, AND PUTTING IT MORE MEDIAL LEFT VISUALIZATION ISSUES WITH DRAPE AROUND THE HEAD. WHAT WAS DONE TO ADDRESS THE FRACTURE? IF NOTHING WAS DONE, WHY NOT?: NOTHING. VERY LATERAL TIP WAS FRACTURED, BUT NOT SERIOUS ENOUGH TO CALL FOR INTERVENTION. PLEASE ESTIMATE ANY SURGICAL DELAY, EVEN IF UNDER A MINUTE (OR INDICATE ¿NONE¿ TO CONFIRM THERE WAS ABSOLUTELY NO DELAY): -3-5 MINUTES. ATTEMPTED TO PUT CLAMP BACK ON TO SEE IF IT WOULD BE WORTH REREGISTERING SCAPULA. DETERMINED THAT THE CLAMP WOULDN'T BE STABLE. CONTINUED ON MANUALLY.

  Patient problems: Insufficient Information

  MAUDE report 25086942 ↗
• InjuryApr 16, 2026Use of Device Problem

  INFORMATION RECEIVED FROM UPPER EXTREMITY SALES TEAM: CORACOID FRACTURE HAPPENED DURING THE CASE WHEN DR. PUT THE CLAMP ONTO THE CORACOID DURING THE MAKO RSA. UPDATE: THE CORACOID CLAMP WAS APPLIED USING THE COMMON SHOULDER DRIVER. WHEN THE PA TIGHTENED THE COMMON SHOULDER DRIVER THE CORACOID FRACTURED. NOTHING UNUSUAL ABOUT THE USE OF THE COMMON SHOULDER DRIVER- JUST THE HANDLE WAS TIGHTENED TO FIRMLY. FRACTURE DID NOT SEEM TO BE TOO SEVERE AND WAS FIXED WITH SOME FIBER WIRE.

  Patient problems: Bone Fracture(s)

  MAUDE report 24894725 ↗