MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 QUICKSET ACE GRATER HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number 244000510

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Prior to use on patient jnj representative was made aware of the "incorrect sleeves for reamer handles".Tops of reamers disengaging.Surgery was completed.No ae to patient.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device was returned.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICKSET ACE GRATER HANDLE
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7903520
• MDR Text Key: 121518383
• Report Number: 1818910-2018-70279
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123798
• UDI-Public: 10603295123798
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/03/2018

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: 244000510
• Device Lot Number: A0308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2008
• 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