MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE CONV FB PS TB TRL SZ9; KNEE INSTRUMENT/TRIAL

Catalog Number	254500979
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The articular surface trial broke in two pieces when removing.
Additional Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Additional Manufacturer Narrative
Additional narrative: examination of the returned device confirms the reported event of trial breakage.Hhe/qrb (quality review board) 103045639 recommended a device correction which was initiated on june 12, 2015.Capa-004795 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-004795 will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor 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 SZ9
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 5702754
• Report Number: 1818910-2016-20265
• Device Sequence Number: 19385608
• Product Code: LXH
• UDI-Device Identifier: 10603295135562
• UDI-Public: (01)10603295135562(10)BFA0LM2
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2016

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
• Operator of Device: No Information
• Device Catalogue Number: 254500979
• Device Lot Number: BFA0LM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: 06/07/2016; 06/07/2016
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 06/07/2016; 06/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR