MAUDE Adverse Event Report: DEPUY RAYNHAM-REG. # 1219655 TRUMATCH ATTUNE KIT LEFT; KNEE INSTRUMENT/TRIAL

Catalog Number 420945

Device Problem Break (1069)

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

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The cutting block broke during resection.

Manufacturer Narrative

Examination of the submitted device confirmed the reported breakage.Review of the device history record did not reveal any manufacturing deviations or anomalies.A design file review confirmed the proposal and block design were with in trumatch specifications.The root cause of the device breakage is unknown.No evidence was found indicating product error was a contributing factor to the device breakage and the need for corrective action is 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 LEFT
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY RAYNHAM-REG. # 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY RAYNHAM-REG. # 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6136098
• MDR Text Key: 61148241
• Report Number: 1818910-2016-32578
• 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: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420945
• Device Lot Number: 077LI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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