MAUDE Adverse Event Report: ACUMED LLC ACUMED; SCREW, FIXATION, BONE

Model Number	30-0329
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor putting screw into patient, screw split in half.Head of the screw is on the sterile field and the other half in the patient's bone.

• Brand Name: ACUMED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass rd; hillsboro OR 97124
• MDR Report Key: 8900884
• Report Number: 8900884
• Device Sequence Number: 1948653
• Product Code: HWC
• UDI-Device Identifier: 10806378018084
• UDI-Public: (01)10806378018084
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2019
• Report Date (Section F): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30-0329
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 86
• Date Report Sent to FDA: 07/25/2019