MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. FEMORAL / TIBIAL EXTRACTOR KNEE REVISION INSTRUMENT

Catalog Number D2421-02-000

Device Problems Break (1069); Unintended Collision (1429)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2020

Event Type  Injury  

Event Description

While attempting to hammer out a femoral implant during an orthopedic surgical procedure, distal end of the osteotome broke off, flew up and struck the overhead light, and landed back on the surgical table.

• Brand Name: FEMORAL / TIBIAL EXTRACTOR KNEE REVISION INSTRUMENT
• Type of Device: EXTRACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 10867844
• MDR Text Key: 217422206
• Report Number: MW5097975
• Device Sequence Number: 1
• Product Code: HWB
• 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: 09/11/2020

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 Catalogue Number: D2421-02-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 101