MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. QUICKSET ACE GRATER HEAD 62MM; HIP INSTRUMENT/TRIAL

Catalog Number 244000562

Device Problem Disassembly (1168)

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

Event Date 02/03/2017

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 base of both graters separated from the actual grater head.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: QUICKSET ACE GRATER HEAD 62MM
• Type of Device: HIP 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: 6359678
• MDR Text Key: 68354775
• Report Number: 1818910-2017-13449
• Device Sequence Number: 1
• Product Code: HTO
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 244000562
• Device Lot Number: A0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2008
• 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