MAUDE Adverse Event Report: AESCULAP AG DUROGRIP; HOLDER, NEEDLE; ORTHOPEDIC

Model Number BM067R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

Part of a needle driver insert fell into a patient during surgery.

• Brand Name: DUROGRIP
• Type of Device: HOLDER, NEEDLE; ORTHOPEDIC
• Manufacturer (Section D): AESCULAP AG; 3773 corporate parkway; center valle PA 18034
• MDR Report Key: 12553747
• MDR Text Key: 274031866
• Report Number: 12553747
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2021,09/13/2021

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
• Device Operator: Health Professional
• Device Model Number: BM067R
• Device Catalogue Number: BM067R
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2021
• Date Report to Manufacturer: 09/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Weight: 80