MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE CONV FB PS TB TRL SZ5; KNEE INSTRUMENT/TRIAL

Catalog Number 254500975

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Although there was no abnormality by x-rays taken just after the surgery, the surgeon found a part of surgical instruments left in the patient's body during routine medical checkup.It was reported that the part seemed to be the balseal of the reported device.There seems to be no anomaly to the patient at this point, therefore they will continue the follow-up observations.

Manufacturer Narrative

The device associated with this report was not returned, however review of the provided x-rays confirms the reported event of a balseal remaining in the patient.Hhe/qrb (quality review board) (b)(4) recommended a device correction which was initiated on june 12, 2015.Capa-(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.Capa-(b)(4) will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor disassociation events per post market surveillance sep-419.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE CONV FB PS TB TRL SZ5
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5614335
• MDR Text Key: 43850663
• Report Number: 1818910-2016-18240
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other