MAUDE Adverse Event Report: DEPUY BRIDGEWATER ATTUNE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 400M

Device Problem Component Missing (2306)

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

Event Date 04/22/2021

Event Type  malfunction  

Event Description

Femoral im (intramedullary) guide rod used in the patient during surgical procedure was discovered to be missing a portion of the tip when returned to the surgical back table.Physician was notified and an x-ray was ordered.Upon looking at the intraoperative x-ray, the missing piece was seen in the patient¿s femur.The item could not be retrieved without causing harm to the patient.

• Brand Name: ATTUNE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY BRIDGEWATER; 50 scotland blvd.; bridgewater MA 02324
• MDR Report Key: 11805569
• MDR Text Key: 250011876
• Report Number: 11805569
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2021

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: 400M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 104