Ankle Compression Nailing System 1 (REF 99-T77225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242512974), received between Jul 21, 2021 and Jul 21, 2021 — classified as 2 malfunctions.

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

• MalfunctionJul 21, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODES: 99-T77225 (QUANTITY 2) AND 177305 (QUANTITY 1) - (THIS REPORTS AND 9680825-2021-00053 AND 9680825-2021-00054) BATCH NUMBER: B1047977 (THE 2 NAILS) AND UNKNOWN. DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT ANKLE. PATIENT INFORMATION: (B)(6), MALE. PROBLEM OBSERVED DURING: HOSPITAL PRE-USE INSPECTION. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "DURING AHN CASE, THE FIRST 2 NAILS OPENED (99-T77225) HAD A STUCK INTERNAL COMPRESSION MECHANISM AND WOULD NOT MOVE. A COMPRESSION DRIVER (177305) BROKE TRYING TO GET IT LOOSE. A 12/300 NAIL WAS OPENED INSTEAD DUE TO THE ISSUE. THIS WAS NOT ABLE TO BE INSERTED DUE TO THE CURVATURE OF THE TIBIA. EVENTUALLY, A 12/200 (99-T77220) WAS ABLE TO BE USED FOR THE PATIENT. WHEN PLACING THE PA CALCANEUS SCREW ON THE NOW 200 SIZED NAIL, IT MISSED THE NAIL COMPLETELY. " THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE OF SAME MODEL WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO A D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201187 ↗
• MalfunctionJul 21, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODES: 99-T77225 (QUANTITY 2) AND 177305 (QUANTITY 1) - (MFR REPORTS 9680825-2021-00052 AND 9680825-2021-00053 AND 9680825-2021-00054). - BATCH NUMBER: B1047977 (THE 2 NAILS) AND UNKNOWN. - DATE OF INITIAL SURGERY: (B)(6) 2021. - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT ANKLE. - PATIENT INFORMATION: 39 YEARS, MALE. - PROBLEM OBSERVED DURING: HOSPITAL PRE-USE INSPECTION. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "DURING AHN CASE, THE FIRST 2 NAILS OPENED (99-T77225) HAD A STUCK INTERNAL COMPRESSION MECHANISM AND WOULD NOT MOVE. A COMPRESSION DRIVER (177305) BROKE TRYING TO GET IT LOOSE. A 12/300 NAIL WAS OPENED INSTEAD DUE TO THE ISSUE. THIS WAS NOT ABLE TO BE INSERTED DUE TO THE CURVATURE OF THE TIBIA. EVENTUALLY, A 12/200 (99-T77220) WAS ABLE TO BE USED FOR THE PATIENT. WHEN PLACING THE PA CALCANEUS SCREW ON THE NOW 200 SIZED NAIL, IT MISSED THE NAIL COMPLETELY. " THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. - A REPLACEMENT DEVICE OF SAME MODEL WAS IMMEDIATELY AVAILABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201186 ↗