MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE FB PS ARTIC SURF SZ6; KNEE INSTRUMENT/TRIAL

Catalog Number 254500506

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 10/07/2016

Event Type  malfunction  

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

The trial is missing one of the balseals.

Manufacturer Narrative

The device associated with this report was not evaluated.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 per post market surveillance sep-(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The investigation has been reopened due to receiving product for evaluation.Depuy will notify the fda when the investigation is complete.

Manufacturer Narrative

Examination of the returned device confirms the reported event of damaged/missing balseals.(b)(4) recommended a device correction which was initiated on june 12, 2015.(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.(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 (b)(4).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 FB PS ARTIC SURF SZ6
• 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: 6029549
• MDR Text Key: 57454566
• Report Number: 1818910-2016-29493
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/07/2016

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: 254500506
• Device Lot Number: MVMCDM190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/29/2016; 11/29/2016; 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2137/2146-2015
• Patient Sequence Number: 1