BITE COMPRESSION SCREWS 1 (REF 001-A-1102P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18056099646741), received between Jul 18, 2018 and Jul 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryJul 18, 2018Fracture; Fracture

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: JEWISH HOSPITAL; - SURGEON NAME:BRIAN ASH; - DATE OF INITIAL SURGERY: (B)(6) 2018; - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FIRST METATARSAL; - SURGERY DESCRIPTION: DISTAL BUNIONECTOMY; - PATIENT INFORMATION: INITIALS AT, 35 YEAR-OLD, FEMALE; - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: PER TM ANDREW WEIL; DURING A DISTAL BUNIONECTOMY WITH DR. ASH. 2 DRILL BITS WITH PART # 001-A-30001 AND LOT B1195371 BOTH DRILL BITS USED WOULD NOT GO THROUGH THE BONE. OR PULLED A SET THAT BELONGED TO A COMPETITOR IN ORDER TO COMPLETE THE SURGERY. UN-RETRIEVED GUIDE WIRE W/PART# 001-A-1102P LOT B1204948 WAS LEFT IN PATIENT'S RIGHT METATARSAL. THIS INCREASED THE DURATION OF THE PROCEDURE BY 5-8MIN. NO ADDITIONAL SURGERY REQUIRED. X-RAYS IMAGES ARE ATTACHED. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LEFT K-WIRE IN PATIENT'S RIGHT METATARSAL TOE - THE SURGERY WAS NOT COMPLETED WITH THE DEVICE - A REPLACEMENT DEVICE OF THE SAME MODEL WAS NOT IMMEDIATELY AVAILABLE TO COMP

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7697861 ↗