FlareHawk FHPACS0025TTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810045530895), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A CASE WHERE A SHIM AND SHELL MISMATCH OCCURRED. A FH9 SHORT SHELL WITH AN FH11 10/12MM SHIM WAS USED AND THIS WAS NOTED WHEN THE SALES ORDER FORM WAS SUBMITTED. A REVISION SURGERY WAS CONDUCTED TO CORRECT THE ERROR. A FOLLOW UP WITH DR. (B)(6) WAS CONDUCTED BY (B)(4) TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT. DR. (B)(6) SAID THEY USED THE LOCK CHECK GAUGE AND THE GUIDE PIN WAS FLUSH WITH THE TOP OF THE INSTRUMENT AND READ AS 'LOCKED'. HE ALSO SAID THAT DR. (B)(6) RARELY USES FH9 AND THE SOFT IMPLANT CASE WASN'T EVEN IN THE OPERATING ROOM. THE FH11 IMPLANTS WERE THE ONLY IMPLANTS IN THE ROOM, WHICH MAKES IT MORE LIKELY THAT THE RESTOCK WAS IN THE WRONG CASE. BOTH NATE BATES AND I WERE ON THE CALL WITH DR. (B)(6) AND WE DISCUSSED THE PROBABILITY THAT THE IMPLANT WAS NOT LOCKED AND ASKED THAT HE SEND IMAGES TO VERIFY. DR. (B)(6) WAS ABLE TO GET THE A/P AND LATERAL IMAGES AND NATE ASSESSED THAT THE WINGS OF THE CORE ARE BROKEN IN THE A/P, WHICH COULD EXPLAIN WHY THE LOCK GAUGE SHOWED THAT THE IMPLANT WAS LOCKED. I ASKED (B)(6) TO SEND BACK THE IMPLANT FOR ASSESSMENT. AFTER HAVING A DISCUSSION WITH DR. (B)(6), DR. (B)(6) DECIDED TO SCHEDULE THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033683 ↗