BITE COMPRESSION SCREWS 1 (REF 001-C-35014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18056099643191), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 15, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: NA; SURGERY DESCRIPTION: BUNION SURGERY; PATIENT INFORMATION: NA; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DURING BUNION SURGERY, SCREWS WOULD NOT ENGAGE WHEN BEING PLACED IN THE PATIENT. THE SIZE 14 DID ENGAGE WHEN USED WITH A 2.5 ARTHREX DRILL BIT. SCREWS KEPT SPINNING NO MATTER HOW MUCH PRESSURE WAS APPLIED. 3 DOCTORS TRIED TO PLACE THE SCREW. PATIENT'S FIRST METATARSAL WAS DAMAGED AND ANTERIOR CORTEX WAS COMPROMISED. THE THREE SCREWS WERE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH THE DEVICE: DR. USED SYNTHESES PLATES AND SCREWS; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: 2.5 HRS; AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COP

  Patient problems: Bone Fracture(s)

  MAUDE report 7272679 ↗