MAUDE Adverse Event Report: DEPUY SYNTHES, INC. DEPUY PATELLA CUTTING DEVICE; INSTRUMENT, CUTTING, ORTHOPEDIC

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Event Description

During tka, an instrument broke and small part came off of patella cutting guide.X-ray called and images of knee taken and read per surgeon.Sterile field examined for piece and magnet used on floor.Piece found on floor and compared to broken instrument off of sterile field, surgeon examined piece as well.Picture taken by industry rep stating he will show picture to mgr of operating room.Instrument was flagged with a repair tag.

• Brand Name: DEPUY PATELLA CUTTING DEVICE
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SYNTHES, INC.
• MDR Report Key: 7689263
• MDR Text Key: 114096108
• Report Number: MW5078379
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• 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: 68 YR