MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ADAPTER X-RAY 3-JOINT WIDE; HOLDER, HEAD, RADIOGRAPHIC

Model Number 1430024

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported the x-ray adapter slipped during a procedure and the patient's head moved.The customer reported the adapter was missing a screw but did not know if it was missing during the case.No patient injury was reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Inspection of the device by a hillrom technician found no issue with adapter, it could be fixed correctly.The technician noted that one screw (clamping screw for longitudinal shift) was missing which did not cause any unwanted movement.The hillrom service technician was unable to duplicate any unwanted movement.The facility's biomed ordered the replacement screw.The device ifu states "test before each use, check that all mechanical functions and parts are undamaged and in good working order, check if all locking screws¿.The event was traced to an use error and is reported based on a potential serious injury in case of recurrence.Based on the findings no further actions are required.

• Brand Name: ADAPTER X-RAY 3-JOINT WIDE
• Type of Device: HOLDER, HEAD, RADIOGRAPHIC
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 13994097
• MDR Text Key: 298325369
• Report Number: 3007143268-2022-00008
• Device Sequence Number: 1
• Product Code: IWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1430024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1