MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE RP PS ARTIC SURF SZ8; KNEE INSTRUMENT/TRIAL

Catalog Number 254500548

Device Problem Break (1069)

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

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Examination of the returned device confirms the reported event of post breakage.Hhe/qrb (quality review board) (b)(4) recommended a device correction which was initiated on (b)(6) 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 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.

Event Description

The foot of the ps rp trial insert snapped off during trialing.

Manufacturer Narrative

: examination of the returned device confirms the reported event of post breakage.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-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 RP PS ARTIC SURF SZ8
• 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: 6122095
• MDR Text Key: 60759636
• Report Number: 1818910-2016-31993
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500548
• Device Lot Number: MVMBTN600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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 Age: 70 YR