GRYPHON PERMACORD 223147Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705024612), received between Aug 5, 2018 and Jan 23, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2023Break; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Break; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HANDLE DISLODGED FROM THE SHAFT WHEN ATTEMPTING TO REMOVE THE INSERTER ON THE GRYPHON¿ BR DS ANCHOR WITH PERMACORD¿ SIZE 2, 36" DEVICE AFTER ANCHOR WAS IMPLANTED. ACCORDING TO THE REPORT, THE ANCHOR REMAINED STRONGLY FASTENED IN THE BONE WITH NO ISSUES WITH THE SUTURES. THEY USED A KOCKER AND A MALLET TO DISLODGE THE SHAFT FROM THE ANCHOR AFTER INSERTION. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE DISTAL PART ON THE DEVICE WAS BENT, AND THE ANCHOR WAS NOT IN THE INSERTER. THERE WERE NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227582 ↗
• InjuryDec 7, 2018Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth; Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth

  THIS IS REPORT 4 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE SALES REP'S GRYPHON BR ANCHORS WITH PERMACORD (LOT: L604137) WERE INSERTED INTO THE PATIENT, BUT AFTER THE SURGEON TIED THE KNOT IN THE SUTURE, THE SUTURE CAME LOOSE. THE SAME FAILURE OCCURRED FOR TWO OF THE SALES REP'S GRYPHON DS ANCHORS WITH PERMACORD (LOT: L918851). THE SALES REP STATED THAT THE CASE WAS COMPLETED BY DRILLING OVER THE ANCHORS TO IMPLANT COMPETITOR ANCHORS. THE SALES REP STATED ANOTHER BONE HOLE WAS CREATED AND A COMPETITOR'S ANCHOR WAS IMPLANTED. THERE WAS NO TIME DELAY TO THE CASE. THE ANCHORS ARE NOT BEING RETURNED, AS THEY ARE IMPLANTED IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 8143624 ↗
• InjuryDec 7, 2018Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth; Entrapment of Device; Loosening of Implant Not Related to Bone-Ingrowth

  THIS IS REPORT 3 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE SALES REP'S GRYPHON BR ANCHORS WITH PERMACORD (LOT: L604137) WERE INSERTED INTO THE PATIENT, BUT AFTER THE SURGEON TIED THE KNOT IN THE SUTURE, THE SUTURE CAME LOOSE. THE SAME FAILURE OCCURRED FOR TWO OF THE SALES REP'S GRYPHON DS ANCHORS WITH PERMACORD (LOT: L918851). THE SALES REP STATED THAT THE CASE WAS COMPLETED BY DRILLING OVER THE ANCHORS TO IMPLANT COMPETITOR ANCHORS. THE SALES REP STATED ANOTHER BONE HOLE WAS CREATED AND A COMPETITOR'S ANCHOR WAS IMPLANTED. THERE WAS NO TIME DELAY TO THE CASE. THE ANCHORS ARE NOT BEING RETURNED, AS THEY ARE IMPLANTED IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 8143620 ↗
• MalfunctionAug 5, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT THE NOSE OF THE ANCHOR BROKE/CRACKED AND THE SUTURE PULLED OUT LEAVING THE ANCHOR SECURELY IMPLANTED WITHIN THE BONE. THE SURGEON COMPLETED THE PROCEDURE LEAVING THE ANCHOR IN THE BONE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP REPORTED THAT THE SURGEON DID NOT USE ANY ADDITIONAL ANCHORS TO FINISH THE PROCEDURE. THE PATIENT WAS A MALE IN HIS (B)(6) WITH GOOD BONE QUALITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750140 ↗