MAUDE Adverse Event Report: CODMAN AND SHURTLEFF CODMAN BOOKWALTER RETRACTOR SYSTEM; RETRACTORS

Model Number	50-4580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Ratchet broke during the or case.Item was removed from surgical field with screw missing.Screw was attempted to be found with a magnet stick.Unable to locate the missing screw in surgical drapes or on the or floor.X- ray obtained to ensure patient safety.

• Brand Name: CODMAN BOOKWALTER RETRACTOR SYSTEM
• Common Device Name: RETRACTORS
• Manufacturer (Section D): CODMAN AND SHURTLEFF; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12567913
• Report Number: 12567913
• Device Sequence Number: 18272474
• Product Code: GAD
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/23/2021
• Report Date (Section F): 09/30/2021

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: Other
• Device Model Number: 50-4580
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/30/2021