MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. TRUMATCH ATTUNE KIT RIGHT; KNEE INSTRUMENT/TRIAL

Catalog Number 420946

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 Description

The trumatch tibial cutting block cracked.Update 04/19/2016 the (b)(4) trumatch attune kit right associated with this report was not returned.A provided photograph of the tibial block confirmed breakage in zone 2.Breakage in this zone location could lead to potential patient harm.

Manufacturer Narrative

The device associated with this report was not returned.A provided photograph confirmed the reported breakage.Review of the device history records did not reveal any manufacturing deviations or anomalies.A design file review confirmed the proposal design and tibial block design were designed with in trumatch specifications.The investigation could not verify or identify any product contribution to the reported event with the information provided.No evidence was found indicating product error was a contributing factor to the device breakage and the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: TRUMATCH ATTUNE KIT RIGHT
• 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: 5586592
• MDR Text Key: 42963731
• Report Number: 1818910-2016-17539
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 420946
• Device Lot Number: 068NX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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