Ankle Compression Nailing System 1 (REF 99-T77020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242512882), received between Dec 3, 2018 and Aug 21, 2019 — classified as 1 injury, 1 malfunction.

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

• MalfunctionAug 21, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. SURGERY DESCRIPTION: OTHER. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: INTERNAL LOCKING SCREW AND COMPRESSION SCREW FAILED TO ENGAGE. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE OF THE SAME MODEL WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (REMOVE NAIL AND INSERT NAIL 20 MINUTES). AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT AND X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: NO RESPONSE. ON AUGUST 20, 2019 ORTHOFIX SRL RECEIVED THE FOLLOWING INFORMATION: THE PART NUMBER OF THE NAIL IS 99-T77020. THE LOT NUMBER PRINTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914449 ↗
• InjuryDec 3, 2018Break; Break

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2017. BODY PART TO WHICH DEVICE WAS APPLIED: HIND FOOT. SURGERY DESCRIPTION: N/A. PATIENT INFORMATION: UNKNOWN. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: PER TM- THE ANKLE HINDFOOT NAIL, 99-T77020 B1047979 BROKE IN HALF. THE CASE THAT WAS DONE AT (B)(6) MEDICAL ON (B)(6) 2017 WITH DR. (B)(6). TM ADVISED THAT SHE WILL NOT BE ABLE TO GET THE NAIL BACK. THE COMPLAINT WAS REPORTED TO THE TM DURING THE LATER PART OF (B)(6). THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: DATE OF THE REVISION SURGERY NOT CONFIRMED YET. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT AND X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: UNAVAILABLE. NOTE: THE REP DOES

  Patient problems: No Code Available

  MAUDE report 8124835 ↗