BITE COMPRESSION SCREWS 1 (REF 001-A-30001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18056099646802), received between Jul 18, 2018 and Jul 18, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Dull, Blunt” (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.

• InjuryJul 18, 2018Dull, Blunt; Dull, Blunt

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON NAME:(B)(6) ; 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. (B)(6). 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 COMPLETE THE SURGERY; THE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7697859 ↗
• InjuryJul 18, 2018Dull, Blunt; Dull, Blunt

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: JEWISH HOSPITAL; - SURGEON NAME:BRIAN ASH; - DATE OF INITIAL SURGERY: 6/22/2018; - 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 COMPLE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7697828 ↗