MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC ATTUNE; EXTRACTOR

Lot Number BFAORRF

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 04/26/2018

Event Type  malfunction  

Event Description

Doctor was performing a l tka (total knee arthroplasty).While removing articulating surface trial, the trial, as well as the trial extractor broke.The trial was removed in its entirety.All pieces of the trial extractor, however, were not accounted for.The wound was thoroughly searched and irrigated thoroughly, and no evidence of foreign body was found.The trial and trial extractor were sequestered and sent to risk for evaluation and reporting.

• Brand Name: ATTUNE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7534418
• MDR Text Key: 108929000
• Report Number: 7534418
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2018

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: Physician
• Device Lot Number: BFAORRF
• Other Device ID Number: 6ZS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR