MAUDE Adverse Event Report: JOHNSON AND JOHNSON DEPUY J AND J ATTUNE FB IMPACTOR

Catalog Number D254401003

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 06/29/2015

Event Type  malfunction  

Event Description

Surgeon was using the attune fb impactor instrument during a total knee replacement and it broke in half.No retained pieces left in surgical wound.J and j depuy rep (b)(4) present in operating room at time of device failure and aware.Device sequestered.

• Brand Name: J AND J ATTUNE FB IMPACTOR
• Type of Device: J AND J ATTUNE FB IMPACTOR
• Manufacturer (Section D): JOHNSON AND JOHNSON DEPUY
• MDR Report Key: 4905702
• MDR Text Key: 6830939
• Report Number: MW5043904
• Device Sequence Number: 1
• Product Code: LXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

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: D254401003
• Device Lot Number: AU3207735
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2015
• Patient Sequence Number: 1
• Treatment: COZAAR; COUMADIN; NORCO; FLEXERIL; URECHOLINE; FERROUS SULFATE; DULCOLAX; PROZAC; COLACE; TYLENOL
• Patient Age: 57 YR
• Patient Weight: 91