MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AGILITY LP HANDLE ASSEMBLY; ANKLE INSTRUMENT/TRIAL

Catalog Number 240410000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Agility lp handle assembly and talar impactor broke during a resident demonstration.

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.

Manufacturer Narrative

Examination of the submitted handle confirmed the threaded shaft is bent.The bent condition indicates side -to-side leveraging has been applied to the handle during use.The overall condition of the instrument indicates heavy usage.The root cause is attributed to misuse.Based on the root cause determination of misuse, the need for corrective action is not indicated.Monitor complaints through trend analysis.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: AGILITY LP HANDLE ASSEMBLY
• Type of Device: ANKLE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6159466
• MDR Text Key: 62377064
• Report Number: 1818910-2016-33008
• Device Sequence Number: 1
• Product Code: HSN
• 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,Followup
• Report Date: 11/15/2016

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: 240410000
• Device Lot Number: PG1206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2016; 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2006
• 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