MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE IMPACTION HANDLE; KNEE INSTRUMENT/TRIAL

Catalog Number 254401017

Device Problem Break (1069)

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

Event Date 03/31/2016

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 attune impaction handle broke during impaction.

Manufacturer Narrative

The complaint states the attune impaction handle broke during impaction.No products were returned hence the complaint cannot be confirmed.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.

• Brand Name: ATTUNE IMPACTION HANDLE
• 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: 5543623
• MDR Text Key: 41717506
• Report Number: 1818910-2016-16562
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/31/2016

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: 254401017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR