GRYPHON 211039Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705001514), received between Sep 26, 2019 and Nov 21, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT PRE-OP TO A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT A GRYPHON SAWTOOTH GUIDE WAS BENT. ACCORDING TO THE REPORT, THE DEVICE COULD DRIVE BUT WOULD NOT FIT DOWN GUIDE. THEY HAD A SLOTTED GRYPHON GUIDE IN TRAY TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838803 ↗
• MalfunctionNov 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT BEFORE STERILIZATION ON 10/21/2022, IT WAS OBSERVED THAT THE GRYPHON SAWTOOTH GUIDE DEVICE WAS BENT. NO PROCEDURE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727009 ↗
• MalfunctionJun 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT IT WAS OBSERVED THAT THE GRYPHON SAWTOOTH GUIDE WAS BENT AT THE TIP WHILE CHECKING THE SETS. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14702811 ↗
• MalfunctionJun 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON SAWTOOTH GUIDE DEVICE WAS NOT STRAIGHT WHEN TESTED OUT WITH TROCAR INSERT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626216 ↗
• MalfunctionMay 9, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GDE DEVICE BROKE INTO TWO PIECES. THERE WERE NO FRAGMENTS GENERATED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337802 ↗
• MalfunctionAug 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT PRE-OPERATIVELY TO A ROTATOR CUFF REPAIR WHILE USING A GRYPHON SAWTOOTH GUIDE, DRILL GUIDE OF HANDLE CAME OFF. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417511 ↗
• MalfunctionJun 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE GRYPHON SAWTOOTH GUIDE DETACHED FROM THE SHAFT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140244 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LABRUM REPAIR THE CUSTOMER'S GRYPHON SAWTOOTH GUIDE GOT STUCK IN THE CANNULA AND THE HANDLE SEPARATED FROM THE REST OF THE GUIDE. THE SALES REP STATED THAT FRAGMENTS WERE NOT CREATED WHEN THE DEVICE BROKE AND THE DEVICE WAS FULLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP STATED THERE WAS NO NEED FOR SURGICAL INTERVENTION. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE A LOT NUMBER OR ANY ADDITIONAL INFORMATION. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9122735 ↗