MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Lot Number J6957H

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

Perforator used for surgery malfunctioned and did not stop like it is designed to.No visual or suspected patient harm.Perforator was saved with packaging and new perforator was opened to use.

• Brand Name: PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.
• MDR Report Key: 10167617
• MDR Text Key: 195946212
• Report Number: MW5095059
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2020

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
• Device Operator: Health Professional
• Device Lot Number: J6957H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR