ANKLE COMPRESSION NAILING SYSTEM 1 (REF 177110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509858772), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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 27, 2018Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 177110 (NAIL ATTACHMENT ROD) . BATCH NUMBER: V1354034. QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE. SURGERY DESCRIPTION: TTC FUSION. PATIENT INFORMATION: (B)(6), MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "PER TM - DURING A TTC FUSION WITH DR. (B)(6). PART 177110 WITH LOT# V1354034 THE NAIL ATTACHMENT ROD. DR HAD REEMED PATIENT AND PLACED THE NAIL IN THE PATIENT. THE DR KEPT MISSING THE HOLES IN THE NAIL. SURGEON TRIED TO FREE HAND THE SCREWS WITH NO SUCCESS. DR. REMOVED THE JIG/NAIL AND IT WAS NOTICED THAT THE NAIL WAS CROSSTHREADED ON THE ROD. UNABLE TO COMPLETE THE PROPOSED SURGERY. SURGERY WAS COMPLETED ALTERNATE PRODUCT". 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 WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SU

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7817547 ↗